Michael Barbella, Managing Editor06.22.23
RQM+ has appointed 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.
“Steve is an excellent fit to lead our lab services business,” RQM+ CEO Margaret Keegan said. “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.”
With more than 30 years of medtech and pharmaceutical 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.
Pilewski earned a master’s degree in pharmaceutical and medical device law and intellectual property from Seton Hall University. He also earned 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 a medtech service provider with the world’s largest global team of regulatory and quality experts. Building upon 40 years of regulatory expertise, the company also provides clinical trial, lab, and reimbursement services—reducing risk throughout the entire product lifecycle for medical devices, digital therapeutics and diagnostics. With more former U.S. Food and Drug Administration, Medicines in Healthcare products Regulatory Agency (MHRA) and notified body regulators than any other firm, the RQM+ team has expertise in all clinical specialties. The firm currently works with 19 of the top 20 medical device manufacturers and seven of the top 10 IVD companies.
“Steve is an excellent fit to lead our lab services business,” RQM+ CEO Margaret Keegan said. “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.”
With more than 30 years of medtech and pharmaceutical 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.
Pilewski earned a master’s degree in pharmaceutical and medical device law and intellectual property from Seton Hall University. He also earned 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 a medtech service provider with the world’s largest global team of regulatory and quality experts. Building upon 40 years of regulatory expertise, the company also provides clinical trial, lab, and reimbursement services—reducing risk throughout the entire product lifecycle for medical devices, digital therapeutics and diagnostics. With more former U.S. Food and Drug Administration, Medicines in Healthcare products Regulatory Agency (MHRA) and notified body regulators than any other firm, the RQM+ team has expertise in all clinical specialties. The firm currently works with 19 of the top 20 medical device manufacturers and seven of the top 10 IVD companies.