PITTSBURGH, April 25, 2023 – RQM+, the world’s leading MedTech service provider, today announced the appointment of Steven Pilewski as chief operating officer for its lab services business unit, which provides chemical characterization and complex product deformulation, as well as contaminant and failure investigations, to MedTech manufacturers. The business unit was founded more than 40 years ago as Jordi Labs, which was acquired by RQM+ in September 2022.
With more than 30 years of MedTech and pharma expertise, Pilewski most recently served as vice president of PPD Laboratories’ Good Manufacturing Practices (GMP) lab, which is a division of Thermo Fisher Scientific. When he began his career at PPD 24 years ago, the GMP lab was a small business with only 50 employees. During his tenure as a member of the executive leadership team, Pilewski continued to drive the business unit’s global organic growth strategy, transforming it into a leading global analytical services enterprise with more than 3,000 people.
“Steve is an excellent fit to lead our lab services business,” said CEO Margaret Keegan. “His experience will help us achieve our growth goals – expanding capacity to better serve our clients, broadening our geographic reach, and innovating to develop new ways to support medical device and diagnostics manufacturers. His deep expertise with extractables and leachables and device testing, which serves as a key differentiator for us, will also help further our reputation as a leader in polymers, quantitation and eliminating unknowns.”
In addition to his leadership experience at both public and private equity owned companies, Pilewski has a master’s degree in pharmaceutical and medical device law and intellectual property from Seton Hall University. He also has a bachelor’s degree in chemistry from the College of New Jersey.
Mark Jordi, formerly president of Jordi Labs, is transitioning to an advisory role and will continue supporting RQM+.
RQM+ is the leading MedTech service provider with the world’s largest global team of regulatory and quality experts. Building upon 40 years of regulatory expertise, we also provide comprehensive clinical trial, lab and reimbursement services – reducing risk throughout the entire product lifecycle for medical devices, digital therapeutics and diagnostics. With more former FDA, Medicines in Healthcare products Regulatory Agency (MHRA) and notified body regulators than any other firm, the RQM+ team has deep expertise in all clinical specialties. We currently work with 19 of the top 20 medical device manufacturers and seven of the top 10 IVD companies.