Type:

full-time

Job Description:

Role:

Quality Director Location:

Conshohocken, PA - preferably able to commute to site at least 3 days per week

Salary:

$120,000-$150,000 base + annual performance bonus + benefits We are currently working with an innovative, growing medical device business that is entering an exciting phase of development and scale. The organisation is looking for an experienced Quality leader to take ownership of the Quality function and play a key role in supporting the company's continued growth. This is a highly visible, hands-on leadership position offering the opportunity to work closely with Manufacturing, Engineering, Operations, Regulatory and Executive Leadership. The successful candidate will have genuine ownership of the Quality function and the opportunity to build, strengthen and develop systems within a growing medical device environment. Quality Director - Must-Have Specification Essential Experience Extensive Quality experience within medical device manufacturing - candidates must have worked on the manufacturing/production side of a medical device business. Proven experience leading Quality at site/plant/manufacturing level, rather than solely corporate or enterprise-level Quality. Strong understanding and hands-on experience with FDA-regulated medical devices and applicable Quality System requirements. Experience working within an

ISO 13485 / FDA QMS

environment, including ownership of quality systems, procedures, documentation and compliance. Strong experience across CAPA, non-conformances, deviations, complaints, audits, change control, supplier quality and risk management. Experience supporting or leading FDA inspections and regulatory audits. Experience with Design/Process controls, manufacturing processes and product quality. Ideally, experience with Class II medical devices. Medicare DME experience is essential, particularly experience with products that are prescribed, patient-worn/used and reimbursed through Medicare Part B. Candidates should have experience operating in a hands-on manufacturing environment, where Quality is directly connected to Production, Engineering and Operations. Leadership & Company Environment Proven experience leading and developing Quality teams. Comfortable being the senior Quality leader in a small or growing organisation, where they will need to be hands-on rather than relying on large corporate support functions. Start-up, scale-up or small-company experience strongly preferred. Entrepreneurial and pragmatic approach, with the ability to build and improve Quality systems rather than simply maintain an established corporate structure. Comfortable working closely with Operations, Manufacturing, Engineering, Regulatory and Executive Leadership. Candidate Screening - Non-Negotiables Before applying, please ensure you meet all of the following: Come from medical device manufacturing. Have held a site/plant/manufacturing Quality leadership role. Have strong FDA and

ISO 13485

experience. Have hands-on experience with medical device QMS and manufacturing Quality. Have experience leading Quality teams/functions. Can commute to Conshohocken, PA at least 3 days per week, or are willing to relocate. Must have DME/Medicare Part B experience. If you meet all of the above criteria and are interested in taking on a senior Quality leadership position within a growing and innovative medical device organisation, we would be very interested in hearing from you. 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