Ground floor opportunity to establish and lead the QA function at a well-funded start up with products that have already collected extensive, positive clinical trials results. The company’s innovative bioactive implants make a significant difference in healing in a common knee surgery that fails too often, thus requiring further operations, risks and costs. Your work would be key to a major advance in orthopedic surgery.
As the top QA person, you’ll report to the CEO, a highly successful industry veteran leading a company that has solid financial support and promising clinical outcomes in over 140 patients to date. The experienced, hands-on individual in this quite visible position will have the charter to build and manage a robust medical device quality program. The range of responsibilities includes developing, implementing and managing the Quality function to ensure that internal and outsourced processes and metrics are aligned to meet regulatory and customer expectations and create the highest product quality. You’ll be directly responsible to implement and maintain systems that assure regulatory and ISO compliance. Lead internal quality functions and external parties to ensure compliance with the company’s Quality program and procedures, including significant interaction with contract manufacturers and other suppliers.
- Lead all aspects of the Quality System, including management of QA aspects of:
- Product design and manufacturing processes, and continuous process improvement.
- Design FMEA, risk analysis and product and process V&V, and document control system.
- CAPA system and complaints handling.
- Serve as point person and interface with regulatory agencies on compliance related issues.
- Support preparation of product approval PMA and 5l0(k) applications.
- Develop, qualify, coordinate internal and external manufacturing Quality System audit program.
- Develop, administer and asses supplier management, audit tracking, and reporting programs.
- Ensure the company is trained and prepared for FDA and notified body inspections.
- Train staff in general quality systems, CAPAs, deviations, change management, root cause analysis, design controls and other key systems; maintain, manage training records.
- Ensure sterility, biocompatibility, biological test/validation requirements per industry standards.
- Maintain and track quality for analysis, control and management reporting; develop metrics to monitor and report on supplier quality and customer complaint trends.
- Establish and conduct management reviews.
Qualifications and skills:
- BS or MS in an engineering or scientific discipline, or equivalent experience and education.
- 10+ years’ successful experience developing and implementing medical device Quality Systems, ideally for implants or PMA products.
- A successful record creating, implementing and managing FDA compliant quality systems in a start-up company, or in a new business unit of an established organization.
- Experience interacting with the FDA, ISO, and notified bodies, including certification inspections.
- Familiarity with statistical principals as they relate to statistical sampling plans.
- Experience working with disposable or implantable medical device manufacturing.
- Energetic, highly organized, pragmatic, self-starter who thrives in a start-up environment.
- Ability to collaborate and communicate at multiple levels internally and with external partners, to effectively present your viewpoint, using excellent verbal and technical writing skills.
- Regulatory affairs knowledge a plus.