Arthrex is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively seeking a Sr Manager - Design Quality Assurance who works directly with the Quality & Design Engineering departments within Arthrex to provide strategic leadership of the corporate quality engineering team dedicated to design and development, manufacturing transfer, risk management and post-market surveillance of FDA Class I and II, EU Class I, IIa, IIb and III medical devices in the achievement of company goals. Excellent communications and analytical skills, strong technical project management skills and a Bachelors’ degree in an Engineering field will be essential for this position. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.
Our ideal candidate for this role is an engaged Design, Quality, or Manufacturing Engineer at a level II or above with an interest in people leadership. Responsibilities include the oversight of the adverse event reporting, complaint investigation, record closure and trending processes within the Product Surveillance function. The Product Improvement QE Supervisor will lead and motivate a staff of Quality Engineer professionals whom are responsible for investigating complaint samples, processing, analyzing, trending, and driving corrective action for product complaint issues in accordance with the requirements of 21 CFR 820 and ISO 13485:2016.
Essential Duties and Responsibilities:
Oversee and lead the activities of the Arthrex, Inc. Quality Engineers/Product Surveillance professionals as assigned by the Product Surveillance Manager.
Coordinate global complaint handling activities between Arthrex, GmbH, Arthrex, Inc. and the subsidiaries.
Motivate and empower the team to initiate and engage in continuous improvement activities.
Foster a team environment where individuals work together to help each other with problem solving, workflow issues, and overcoming barriers to success.
Champion the product recall, adverse events, and emerging issues processes; others as assigned.
Coordinate field corrective actions between Arthrex and the FDA and other international regulatory agencies.
Implement improvements to the Quality Management System and software as related to complaints, adverse events and product / field corrective actions.
Assign projects, schedule work assignments, and train new employees.
Assist in the administration of performance reviews and disciplinary action when necessary.
Meet departmental process efficiency goals for all product complaints from receipt to closure.
Interface with internal and external customers, including distributors, suppliers, healthcare professionals, engineering, marketing, regulatory, accounting, and legal departments to accomplish goals.
Cover various department functions during times of short staff.
Assure that systems and personnel keep pace with new requirements, techniques, work flows, and increased volume.
Research and resolve business transaction conflicts.
Maintain a current knowledge of regulations affecting the department.
Provide status reports related to quality and efficiency goals.
Participate in FDA, MDSAP, and international 3rd party audits and inspections as a department representative.
The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.
Education and Experience:
Bachelor’s degree required in an Engineering or Engineering Technology discipline
3 years of progressive experience working in a Quality Assurance, Regulatory Affairs, or similar function required
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Working knowledge of ISO, FDA, MDD /MDR and international medical device / drug quality requirements.
Excellent customer service skills required.
Demonstrated leadership qualities required– Leading by example, meeting challenges in a positive way, and a proactive, strategic mind-set.
Machine, Tools, and/or Equipment Skills:
Proficiency in Microsoft Office applications is required.
Knowledge of Pilgrim Smart Solve, Open Text Documentum, SAP and /or Agile is a plus.
All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Arthrex is a global medical device company and leader in new product development and medical education in orthopedics. With a corporate mission of helping surgeons treat their patients better, Arthrex has pioneered the field of arthroscopy and developed more than 11,000 innovative products and surgical procedures to advance minimally invasive orthopedics worldwide.
Arthrex continues to experience unprecedented growth and demand for our products throughout the world; however, we remain a privately held company with a family business culture committed to delivering uncompromising quality to the healthcare professionals who use our products, and ultimately, the millions of patients whose lives we impact.
We invite you to learn more about Arthrex and the positive contributions we are making to medicine and the communities we serve.