What are the responsibilities and job description for the Associate Director, Quality Assurance - Remote position at Merck?
Merck Associate Director, Quality Assurance - Remote Honolulu, Hawaii Apply Now
Reporting to the Director of Medical Device and Combination Product Quality Assurance, the Associate Director Quality Engineering & Quality Assurance is responsible for independent compliance support of Medical Devices including the device constituent part of Combination Products. This position will interact with cross functional teams working with all levels of employees. Activities will include developing, documenting, and maintenance of technical business solutions, reviewing and approving medical device / combination product documentation to support regulatory filings and audits of data, policies, procedures, and systems to ensure compliance with Medical Device (21CFR 820s) and Combination Product current Good Manufacturing ruling (21CFR part 4), Device Risk Management (ISO 14971) and other worldwide regulations and requirements. This position provides Device quality engineering, quality assurance support and leadership to ensure successful quality oversight of prospective medical devices and medical device combination products.
Primary activities include, but are not limited to :
- Actively represent Medical Device and Combination Product Quality function on commercial and product / core development teams supporting quality issues related to medical devices or the device constituent of a combination product.
- Review and approve Design Control and Device Risk Management documentation for regulatory filings, clinical supply, development, design transfer qualification and post marketing surveillance. Evaluate deficiencies and assess impact on compliance status.
- Contribute to developing / revising policy and procedures for Medical Device and Combination Product Quality and / or supported areas. Remain informed of industry trends as described in worldwide regulations and industry standards.
- Provide guidance to stakeholders to ensure end-to-end Design Control principles are implemented effectively.
- Participate in design reviews, CAPA reviews, and ad-hoc technical reviews of combination products. Participate in all stages of combination product development including but not limited to oversight of purchasing controls and supplier quality.
- Work with external partners to develop products.
- Review and approve verification / validation test protocols and reports to ensure that the testing is sufficient to meet regulatory requirements and quality objectives.
- Provide input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested.
- Facilitate translation of customer needs into critical to quality and design input / output requirements, including but not limited to chemical, physical, or performance specifications.
- Lead and manage development of Global Design file (Design History File) deliverables for medical devices.
Skills
Preferred experience and skills :
Qualifications :
J-18808-Ljbffr
