Authorizations

·        Issue Certificates of Conformance (CoCs) for finished products.

·        Review and approve finished product Certificates of Analysis (CoAs).

·        Issue batch records and other production documentation.

·        Issue Supplier and Technical Agreements.

·        Perform internal (1st party) and external (2nd party) audits.

·        Perform non-conformance and CAPA investigations.

·        Perform field corrections / recalls

·        Hold batches from commercial release.

·        Release batches after quality analysis.

·        Release, make effective, archive, and control revisions and versions of documents.

·        Access and control archived documents.

Recommended Requirements

Technical Skills:

Bachelor's degree in Science/Engineering, or related scientific discipline.

Master’s degree in the relevant technical fields is strongly preferred.

10+ years of experience in a cGMP regulated environment.

5+ years of direct management of a Quality System in Quality Assurance or Regulatory Affairs. Experience should include QA activities pertaining to designing of product, equipment control, verification/validation, production and process control, risk management, document and record control, training control, nonconformance investigations, CAPAs, change controls, data trending and reporting,

4+ years of medical device manufacturing experience with a working knowledge of FDA requirements as per 21 CFR 820, ISO 13485:2016 and/or ISO 14971.

5+ years of supervisory or managerial experience.

Experience with releasing batches for commercial use.

Certified Lead Auditor; or ASQ certification as a Certified Quality Auditor (CQA) and/or Certified Biomedical Auditor (CBA); or Certification with a recognized Accreditation body (i.e. RAB-QSA / IRCA) strongly preferred.

Experience overseeing MDSAP program.

Familiarity with medical device regulations, requirements and standards, including FDA’s 21 CFR Parts 50, 54, 56, 803, 806, and 812, EU Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, ANVISA, ISO 9001, ISO 14155, and ICH E6.

Proficient in the use of Microsoft Excel and Microsoft Word.

Strong computer skills, with proficiency in electronic document management systems. Experience with Sharepoint, PowerBi, and other automation tools preferred.

Lean Six Sigma Certification preferred.

Soft skills:

·        Requires strong leadership skills. Ability to interact with and influence diverse cross-functional teams and senior management.

·        Excellent analytical, communication, presentation and writing skills including technical writing.

·        Organized with high attention to detail.

·        Ability to multi-task and work with minimal supervision.

·        Exceptional interpersonal skills, and the ability to work cooperatively and collaboratively with others.

·        Ability to handle a wide set of responsibilities and wear multiple hats.

·        Ability to demonstrate resiliency, take initiative to solve problems and generate high productivity

·        Ability to meet deadlines and deliver work timely in a fast-paced and changing business environment.

·        Proactive, results driven, decisive, and responsive.