Full job description Description: Responsible for the support and maintenance of the Quality System. The candidate ensures that the products produced meet both external and internal requirements, including regulatory compliance and customer specifications within a highly regulated medical device environment. Responsible for review, approval, and oversight of quality related activities and related documents. Proactively identifies areas for continual improvement of quality processes and overall Quality System. Maintains confidential information, including proprietary company and product information.
Responsibilities: Controls of all site-specific quality documents (operating procedures, work instructions, engineering drawings, forms, other) Maintains controlled documents and records for security, confidentiality, and ease of use. Files, tracks and/or retrieves archived information on a routine basis. Maintains the archive system for off-site storage so that documents, records, and files can be easily retrieved for audit and review purposes Reviews and approves Document Change Orders (DCO) and associated controlled documents prior to release for use, including QC testing instructions, raw material specifications, master forms, procedures describing manufacturing processes through distribution. Performs lot release - reviews product-related records (Device History Record) for completeness and accuracy and conformance to specification and approves product for distribution. Reviews and approves manufacturing planned product deviations and nonconformance's and related product/material disposition Collaborates with subject matter expert on CAPA investigation, Corrective and Preventive Actions, and assesses CAPA effectiveness Documents, tracks, and oversees Complaints through resolution Reviews any Quality Inspections records for incoming product/material Initiates and tracks Supplier Corrective Action Requests (SCAR) and collaborates with supplier to resolve issue Skills: Quality assurance, ISO 13485, Quality control, Medical device, Quality system, Document control, Regulatory
Additional Skills & Qualifications: Bachelor's Degree in Life Science, Engineering, or other relevant field preferred . 3+ years of working quality experience within the medical device industry 4-5 years' experience in a GXP regulated field or function, preferably in the medical device industry Experience working with 3rd party vendors/suppliers (nice to have) Strong knowledge of quality assurance and quality systems principles in a highly regulated industry (preferably medical devices, tissue-based products experience a plus) Working knowledge of FDA and ISO regulations / standards, including ISO .13485 and 21 CFR 820 Knowledge of EU Medical Device Directive (MDD), Medical Device Regulations (MDR), and Medical Device Single Audit Program (MDSAP) a plus About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
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