SUMMARY Provides support for and leadership of critical quality assurance activities that are a part of new business quality planning, ongoing manufacturing and quality system support, change activities, supplier management, and process improvements in a regulated medical device manufacturing environment.

ESSENTIAL DUTIES AND RESPONSIBILITIES

As part of a project team bringing new products into the QMS, acts as the quality assurance representative assuring the planning and completion of quality system required activities. These products may be finished devices or more complex device components that cross multiple manufacturing technologies. Acts as the primary liaison with QA peers at client organizations in the day-to-day maintenance of the business. Work with Engineering and Engineering Project Management during change activities, utilizing appropriate quality tools to ensure changes are thoroughly evaluated for elements of risk, validation status, and effects on customer requirements. Ensures that changes are controlled and include a clear implementation plan. Prepares, executes, and documents various quality related studies and exercises such as FMEAs, MSAs, Validation Plans, Capability Studies. Leads cross functional teams in the completion of these activities. Owns Corrective and Preventive Actions or Complaints and completes investigations, documents corrective action plans, and monitors progress toward closure within timeframes set forth in documented procedures. Manages the qualification of critical vendors including the planning, execution, and documentation of testing activities to assure that provided products or services will meet documented requirements. May serve in any several roles during regulatory and internal audits including scribe, back room, and auditee roles as required. Summarizes, graphs and reports quality system data to prepare presentation materials for Management Review meetings. Leads or participates in supplier audits. Performs training in or acts as a resource or internal consultant on Quality System procedures and processes, quality analysis techniques, or statistical methods. Creates or revises quality system SOPs as assigned. Other duties may be assigned.

Bachelor’s degree (BS) from four-year college or university; plus a minimum of five (5) years relevant experience, preferably in medical device or pharmaceutical manufacturing. An equivalent combination of the above education and/or experience.

Additionally 5+ years hands on experience in a GMP environment; Valid drivers license; ASQ Quality Manager, Quality Engineer or Auditor Certifications a plus; Six Sigma Green or Black Belt Training a plus; Ability to occasionally travel to visit customers and/or suppliers

401(k) plus matching; Dental insurance; an Employee assistance program; Health insurance; Health savings account; Life insurance; Paid time off; Professional development assistance; Referral program; Tuition reimbursement; and Vision insurance