Peter Mincieli

Senior Quality and Regulatory leader with over 35 years of experience in medical device quality systems, FDA submissions and GMP compliance. Proven expertise in developing and implementing risk-based quality frameworks and computerized system validations. Demonstrated success leading cross-functional teams through regulatory approvals and building quality infrastructures that drive continuous improvement across global organizations.

V.P. Quality / Regulatory at S2ORTHO (2006-01 – Present)

• Guided company through applications of new devices to FDA and managed computerized system validation efforts
• Assisted in finalization of new product designs ensuring risk-based decision making and FDA compliance
• Designed packaging of new products
• Developed and implemented new quality management system, including clinical quality SOPs to ensure compliance and risk-based decision making
• Provided ongoing quality oversight of daily operations, including CAPA management and inspection readiness activities

V.P. Quality / Regulatory (Contract) at Nutek Orthopaedics (2017-01 – 2022-01)

• Guided company through applications of new devices to FDA and oversaw vendor qualification and oversight
• Finalized the design of new products
• Designed packaging of new products
• Established sales tracking system
• Monitored day-to-day operations, including TMF/eTMF quality oversight and inspection readiness activities

CEO at BMI (2015-01 – 2021-01)

Medical Device Sales

• Hand-picked to finalize the infrastructure of this company's dynamic sales operation
• Acquired correct talent in all functional departments and guided them in implementing all of the necessary documentation for new processes
• Finalized functional groups within two months

Chief Operating Officer (COO) at MDS (2015-01 – 2014-01)

Medical Device Design & Development

• Selected to establish operating infrastructure of this new and innovative device company
• Built all departments into separate functioning units with no issues
• Implemented distribution system for exchanging implant/instrument sets

President at HealthLink Associates (2014-01 – 2015-01)

Initiated restart of company as medical device consulting firm

Consultant at MDS (2000-01 – 2008-01)

• Managed company's regulatory aspect, quality, product design and implementation, process improvement, and technical assessment of technologies to be acquired
• Sourced to write and implement company's entire quality system to allow company to produce medical devices for sale
• Wrote FDA application for first product approval

Senior Vice President at Z-KAT, Inc (1981-01 – 1998-02)

• Guided company through applications of new devices to FDA
• Assist in the finalization of the design of new products
• Designed packaging of new products
• Writing New Quality system
• Monitor day to day operations

Director New Technology Development at Howmedica (1991-01 – 1995-01)

Assistant Director of New Manufacturing Technology at Howmedica (1986-01 – 1991-01)

Manager, Special Projects at Howmedica (1981-05 – 1982-06)

Senior Manufacturing Engineer at Howmedica

Mechanical Engineering – Newark College of Engineering