Hello! I'm Michael
Highly-skilled, intuitive manufacturing leader with particular expertise building, integrating, and refining quality systems. Superior analytical and problem-solving capabilities. Exceptional project manager, team builder, and tactical planner. Skilled at collaborating with cross-functional teams and industry stakeholders to drive organizational excellence and innovation. Instrumental in process engineering, production enhancement, revenue augmentation, and client solutions delivery. Excellent written, verbal and interpersonal communication skills
Quality Engineering & Manufacturing Executive
Technifab Inc., Avon, OH 2019-2022
DIRECTOR OF QUALITY
Driving continual improvements through the implementation of Corrective Actions and subsequent Verifications of Effectiveness.
Leading multiplant team in reducing the need for inspection through data analysis and risk mitigation
Delta Systems, Streetsboro, OH 2013 – 2019
DIRECTOR OF QUALITY
Achieve annual customer return rate of 17 ppm, surpassing industry benchmarks.
Drive initiatives to slash annual warranty costs by 78%, from over $362K to $78K.
Deliver strategic oversight of corporate ISO 9001 Quality Management System build, implementation, and awareness training for manufacturer of safety switches and electronic control modules.
Spearhead comprehensive regulatory compliance, critical supplier selection and qualification, and incoming, in-process, and finished product inspection.
Develop high-performing, cross-functional team to ensure REACH, ROHS, Prop 65, Conflict minerals, and other regulatory compliance.
Successful led ISO 2001:2015 recertification audit; recognized with no systematic issues.
Pioneer redesign of Supplier Quality Management System detailing supplier classification(s), qualification process, performance metrics, scorecards, audit(s), and corrective action requirements (SCARS).
Ensure superior customer support with efficient resolution, return, recall and containment processes.
NDI Medical | Cleveland, OH 2005 – 2013
DIRECTOR OF OPERATIONS AND QUALITY
Reduced resource needs by 90% through implementation of innovative digital document management system.
Provided expert leadership to comprehensive operations, with particular Quality, and IT responsibility, of neuro-stimulation medical device manufacturer.
Directed corporate ISO 9001, ISO 13485 and 21CFR 820 Quality Management System development, integration, and awareness training.
Ensured superior customer support and maximized retention with efficient resolution, return, recall and containment processes.
Successfully led the FDA facility registration process.
Secured favorable contracts with, and steered onboarding of, contract manufacturing, warehousing and distribution supplier; improved supplier qualification development program.
Lead Management Representative for Registrar, FDA and UL audits with no systematic issues identified.
Oversaw post-market surveillance and development and deployment of robust FDA/MEDDEV compliant customer complaint process, including appropriate MDR filings.
Launched stage gate approach to new product development, commercialization and production
Orchestrated critical quality sections of PMA and 510k submissions.
Overhauled risk management process to empower more rapid and timely risk management activities.
Established formalized product-controlled build procedures and establishment of DHR’s.
Gyrus/ACMI | Norwalk, OH 2003 – 2005
QUALITY ASSURANCE MANAGER
Led plant post market surveillance, customer service/complaint processing and MDR filing for medical device manufacturer of urology and gynecology surgical instruments.
Empowered rapid supplier performance analysis with integration of digital data optimization system.
Drove inspection, MRB and inventory improvements; propelled 50% output increase by optimizing workstreams across production planning, quality assurance, and logistics, and slashed delivery time 60%.
AMRESCO | Solon, OH 06/2003 – 12/2003
REGULATORY AFFAIRS MANAGER
Expertly advised owner and president of high purity biochemical and reagent manufacturer.
Provided regulatory and quality oversight; Initiated a rewrite of entire quality system to eliminate unnecessary complexity and redundancy projected to reduce overall documentation by 50%.
Sunrise Medical Products | Avon, OH 2002 – 2003
MANAGER OF QUALITY ASSURANCE
Implemented Lean operations improvements to production lines through value stream mapping which resulted in 50% line-footprint reduction while improving efficiency by 50%.
Team leader on a continuous improvement project to reduce transactional overhead of a KANBAN System and reduced required resources by 90%.
Managed post market surveillance, customer service/complaint processing, and MDR reporting.
Pechiney Plastic Packaging | Bellevue, OH 02/2002 – 07/2002
MANAGER OF QUALITY ASSURANCE
Provided strategic direction to comprehensive plant quality strategy for a plastic bottle manufacturer for food industry; Identified over $500K in cost savings through process improvement and scrap elimination.
UV Coatings LTD | Berea, OH 1998 – 2001
COO/DIRECTOR OF QUALITY ASSURANCE
Provided strategic oversight of operations and quality departments for leading formulator of custom engineered UV cured coatings for wood, metals and plastics.
Developed critical sales lead ranking and selection methodology to enable resource allocation toward high-profit and high %LOS projects.
Orchestrated production planning, materials management, manufacturing, maintenance, logistics, and technical service; launched production management system to optimize batch formulation manufacturing operation.
Integrated innovative DFSS techniques into the new product development process comprising project scoping, reliability requirements, and statistical confidence levels for performance testing and decision making.
Deployed quality management system software package; launched cutting-edge ISO9001 certified quality system.
Built production control and quality system for an overseas blow molded HDPE and PP film plant.
Drove cost savings and reduction initiatives to with oversight of P/L accountability.
Master of Science | Chemical Engineering | Case Western Reserve University | Cleveland, OH.
Bachelor of Science | Chemical Engineering | Case Western Reserve University | Cleveland, OH.
See my public profile at: http://www.linkedin.com/in/michaelhaessly
Founder - Business Improvement Services, LLC
Michael created and conducted customized Quality Auditor training for our Internal Quality Audit team at Sparton Medical in Strongsville. The training utilized Michael's extensive ASQ training and medical device experience. The course allowed us to expand our audit skills while increasing our auditor pool without having to send people off-site. In addition, the training was a great mix of audit body of knowledge and hands on experience. February 6, 2015
Margaret Heuser - Quality Director at Sparton Medical
Director of Operations and Quality - NDI Medical, Inc.
During the four years that I have worked with Mike, I have found him to be professional, hard working, and thorough in his attention to detail. Mike has vast experience in setting up a quality system that incorporates the best practices that he has learned throughout his professional career. Mike’s exposure to high volume manufacturing, managing supplier relationships, and growing value in a company are all assets that Mike brings to the table. I can confidently recommend Mike Haessly for any management level position in quality, manufacturing, and/or operations. - October 28, 2009
Joe Mrva, Director of Engineering, NDI Medical
worked with Michael at NDI Medical, Inc.
I had the opportunity to work with Mike to support his efforts to improve quality and risk management business processes. I learned a lot form Mike and respect his ability to work from the plant floor to the Boardroom. Mike understands the business drivers and how to sell organizations on the ROI of quality. - January 23, 2009
John M. Cachat, Chairman and Founder, IQS
was a consultant or contractor to Michael at NDI Medical, Inc.
Michael developed and implemented a Quality System at NDI Medical that made product development more streamlined and efficient. The policies and procedures he authored are cohesive and practical at both the system and implementation levels. His experience and expertise in product development make him a tremendous resource to the engineering group and an important asset to the company. - December 11, 2007
Jonathan Sakai, Mechanical Engineer, NDI Medical
worked indirectly for Michael at NDI Medical, LLC
Mike is quite simply one of the finest colleagues I've ever had the opportunity to work with. He's competent, goal-oriented, focused, tenacious at making things happen, has an excellent strategic vision, and knows well what differentiates good companies from great companies. Mike is an incredible asset and I learned a great deal working with him. - November 5, 2007
Chris Thierfelder, Sr. Project Director, NDI Medical, LLC
worked indirectly for Michael at NDI Medical, LLC
I’ve had the distinct pleasure of working for Mike for several years. He is a true Quality professional with strong leadership skills and a diverse industry knowledgebase. - He leads by example and empowers his people. - He encourages the continuing growth and development of his staff. - He works well with all personnel levels of an organization and is highly respected by his peers. - He has the unique ability to consistently focus on the Big Picture€ of leading organizations and not get bogged down with day to day micro-management. - He has an excellent Dollars and Sense approach to leading an organizations management staff in all aspects of the corporate system. - He has a very broad materials and product knowledgebase that diversifies his industry skill level. - He has a very strong new product development background having worked in this area for several years. - His six (6) American Society for Quality€ (ASQ) certifications support his commitment to global Quality. - He can lead a company in obtaining various U.S. and global certifications to include ISO9001:2000 and ISO13485:2003 I could go on and on about Mike and his abilities but will stop here. Any company, in any industry that is interested in adding Mike to their organization would not be disappointed. He is an honest industry professional who I have had the unique pleasure of working with. - November 5, 2007
Bill Litvak, Senior Quality Assurance Engineer, NDI Medical Inc.
reported to Michael at NDI Medical, LLC
I've worked with Michael for the last two years. During this period, he's consistently shown an extremely high level of knowledge about quality systems and quality standards, particularly in the medical device industry. More importantly, he's demonstrated his commitment to quality through his daily attention to details and methodologies as he has brought a new quality system online at NDI Medical. He is always willing to help and is always available -- even if it means extending his already overly long work hours. His technical knowledge of product development and engineering practices is also extensive. His leadership skills, especially during times of stress (such as a FDA audit), have been outstanding. I would highly recommend him for any leadership position in quality or product engineering role. - November 4, 2007
Jim Coburn, Director of Operations, NDI Medical
worked directly with Michael at NDI Medical, LLC
Quality Assurance Manager - ACMI Corp.
Michael did an exceptional job at the ACMI plant in Norwalk, Ohio leading the organizational transformation from an outdated "inspect the quality in" approach that had been ingrained for many years to a true process control mentality. Many QA professionals are well versed in statistical techniques. What separated Michael from the pack in my experience was his ability to quickly identify and apply the appropriate statistical tools or approach to a particular problem or improvement opportunity. His ability to move us forward by teaching the organization in this regard was exemplary. - October 14, 2009
Joseph Flanagan, Vice President, QA/RA, ACMI
managed Michael at ACMI Corp.
Michael is a top notch leader and a highly regarded team member. His structured problem solving approach coupled with his command of statistical tools makes any Quality problem solvable.
Graciela Denis, Corporate Sr QA Engineer/Quality Systems Manager, ACMI Corp
worked indirectly for Michael at ACMI Corp.
Michael is a terrific Quality Manager and a better person. I work with him at ACMI. He has taught me a lot and helped me in many ways. I wish more people in this world were like Mike. - October 25, 2005
worked directly with Michael at ACMI Corp.
Quality Assurance Manager - Sunrise Medical
Michael has a very good understanding of Quality and Operations. He worked well with his peers and direct reports. Michael made a positive contribution to the overall success of the organization. - April 1, 2009
Mark Murphy, Sr. Project Manager, Sunrise Medical Inc.
worked directly with Michael at Sunrise Medical
COO / Director of Quality Assurance - UV Coatings, Ltd
Mike accomplishes whatever he sets out to do by utilizing all available resources at his disposal. There is not a hurdle that Mike cannot overcome with his hard work, intelligence, and common sense. Mike has great dedication to his job and his problem solving skills are unmatched! - March 29, 2009
Michael Koons, Technical Service/Sales, UV Coatings, Ltd.
worked indirectly for Michael at ACMI Corp.
Mike is one of the most innovative, forward thinking, trustworthy, and passionate business leaders that I have ever work with. His innate sense of organizational effectiveness combined with an ability to get the most out of his people was inspirational. He was a leader, a mentor, a teacher, but most importantly a friend. If Mike called me tomorrow and asked me to join his executive team, it would be hard for me to say no. - October 16, 2009
Dave Pavlick, Sales, UV Coatings
worked directly with Michael at UV Coatings, Ltd
I have known Michael Haessly since June 1998. He was hired to establish Quality Assurance policies and procedures that lead to successful ISO 2001 Certification of UV Coatings, Ltd.
UV Coatings, Ltd. was established in 1996 to commercialize formulations and technology that I developed in the area of Ultraviolet materials, equipment and methodology. With Michael's assistance, UV Coatings grew from a one man start-up to a multi-departmental company employing over 20 people. Such growth required an individual highly skilled in not only Quality Assurance but experience in Operations Manufacturing, Product and Process R&D and Regulatory Affairs. Michael Haessly came to our attention as a individual that had the skill set we sought. We were lucky to have lured him away from Energizer.
While we originally hired Michael for his skills in QA, became apparent that limiting him to just that position would be greatly underutilizing his skills. Upon this engagement, Michael handily established QA protocols and started the process for successful ISO certification. Even before our ISO Certification, he was promoted to the position of COO. His skills from Energizer meshed perfectly with the position he was promoted to.
Michael is a highly adept and effective manager. While he has world class credentials and certifications, he is able to communicate with every level of employee respectfully and effectively. While Michael is highly personable, he is also able to maintain motivational interpersonal relations at the same time maintaining the goals and best interests of the company. - December 20, 2011
Andy Sokol, Founder, Partner and Director of Research and Development, UV Coatings, Ltd.,
managed Michael indirectly at UV Coatings, Ltd
Certified Manager of Quality/Organizational Excellence (CMQ/OE) (formerly CQM)
Certified Quality Auditor (CQA)
Certified Reliability Engineer (CRE)
Six Sigma Black Belt (CSSBB)
Certified Quality Engineer (CQE)
Certified Software Quality Engineer (CSQE)
Quality, Engineering & Manufacturing Executive
25+ years transforming manufacturing environments with cutting-edge quality strategy and operational leadership.
Highly-skilled, intuitive manufacturing leader with particular expertise building, integrating, and refining quality systems. Superior analytical and problem-solving capabilities. Exceptional project manager, team builder, and tactical planner. Skilled at collaborating with cross-functional teams and industry stakeholders to drive organizational excellence and innovation. Instrumental in process engineering, production enhancement, revenue augmentation, and client solutions delivery. Excellent written, verbal and interpersonal communication skills.