Title: Sr Director, Quality Assurance (Medical Device) 

Location: Allentown, PA

Type: Direct-Hire  

Start date: Immediate  

Responsibilities: 

• Responsible for Lead a team of direct and indirect quality functions with accountability for the Medical Device Franchises Quality Assurance and Compliance programs goals.  Accountable to ensure all products are designed and produced to meet specifications, regulatory body, and our client's standards.
• Support Business unit management to meet their division objectives through the franchise quality goals.
• Represents the Corporate Quality voice in any Franchise leadership strategy meetings, manufacturing plant reviews, multi-functional meetings related to Medical Devices, and design projects.
• In alignment with the Corporate Compliance team, manage the franchises compliance program required portions of cGMP (QSR) 210/2011/820, Medical Device Regulation (MDR), Canadian Medical Device Directive, CFDA, PMDA and other agencies.
• In alignment with the Corporate Quality Systems team, manage and drive QMS compliance remediation as necessary.
• Oversee the franchise QA metrics (KPIs) to track Quality initiatives and effect overall improvements QMS activity.
• Responsible for keeping the Corporate Quality and Business management teams informed of quality status of products, manufacturing sites, and key projects.
• Coordinate FDA required post-market surveillance programs with Corporate Post Marketing Surveillance Department.
• Lead and manage investigations for product field actions and/or recalls, as applicable.
• Facilitate driving a Quality culture and the Corporate strategy for a single QMS into the Medical Device Operations team.
• Develop and maintain the Medical Device franchise quality department budget, including manufacturing site resourcing for daily operations and special projects.
• Lead and/or participate in multi-departmental and multi-site teams to implement quality strategies.
• Represent our client  with Regulatory Authorities related to product and quality issues in the Medical Device franchise.
• Review and approve document changes for Quality Assurance Departments as required.
• Ensure an understanding of the external regulatory requirements with key franchise and business personnel, in order to adapt product quality strategy accordingly.

Requirements: 

• Bachelor's degree required, Master's degree preferred.
• 10-15 years related experience in medical device highly preferred plus a minimum of 7 years management experience required.
• Regular and predictable attendance
• Requires breadth of professional field and industry knowledge.
• Ability to integrate critical information and champion advanced strategies/concepts through the organization.
• Drives development of advanced technologies, principles and processes.
• Directs the activities of a broad functional area through division heads who are responsible for planning, budgeting, costs, methods and employees.
• Determines actual organizational structure and allocation of resources.
• Occasional business travel required, Valid driver's license and passport

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, and MOUNTAIN, LTD., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.