Growing Medical Device manufacturer located in Northern Virginia has an immediate need for an experienced Quality Assurance Manager to assume a leadership role and manage the overall quality function within the facility. The ideal candidate will have 3 to 5 years of experience in a Quality Management leadership role in a highly regulated industry, preferably with medical devices.
Duties and Responsibilities:
Champion the overall Quality function of the facility
Sets compliance objectives and ensures target goals are attained
Develop, implement and manage processes or practices related to SOP's to ensure regulatory compliance
Identify quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies
Produce/review audit reports and conduct follow-up evaluations on corrective/preventative measures that address non-compliance
Manage, coach, counsel and mentor Quality Assurance and Document Control Team members
3-5 years experience in a highly regulated industry required
Bachelor's Degree in Life Science field of study, Engineering or 5-7 years of progressively more responsible experience in a similar leadership role
Strong technical/medical writing skills and exceptional verbal communication abilities required
Professional Engineering Certification and/or ASQ Certification, knowledge of FDA Regulations (Medical device) and ISO 13485-2016 is strongly
Additional Salary Information: We offer the successful candidate a competitive salary and a wide array of Employee Benefits including: Medical, Dental, Disability, 401k, FSA, etc.