Quality Assurance Manager
1 week ago
We are seeking a highly skilled and experienced Engineering Recruiter to join our team.
Key Responsibilities:- Represent the Quality function in Site Management meetings as required.
- Act as a delegate for the Quality Lead, providing guidance and support when needed.
- Lead and implement significant process improvements, projects, and cost-saving initiatives using data and quality tools to drive quality decisions.
- Initiate project plans, identify resource allocations, perform, and guide technical activities such as risk documentation, procedural updates, test methods, and process/software validation that have major importance to the business.
- Lead investigations and provide technical guidance to peers in relation to Software Validation, CAPAs, NCs, and compliance issues, while also guiding engineering teams.
- Implement robust solutions and lead cross-functional teams to achieve project objectives.
- Independently assess and provide guidance to Quality and Engineering disciplines, ensuring adherence to regulatory requirements.
- Perform and lead internal and supplier audits, facilitating external regulatory body audits, e.g., ISO and FDA.
- Bachelor's Degree or higher in Engineering or Science related field (minimum level 8).
- Five years' experience working in regulated environments, specifically medical device, FDA, or ISO 13485 registered work environments is preferable.
- Lead Auditor or Internal Auditor certification an advantage.
- Experience with the use of JIRA, Qtest, and VERA for documenting software lifecycle is advantageous but not essential.
- Knowledge and experience of Oracle, FactoryTalk applications, PEMAC, and Bartender is advantageous.
Hybrid Eligible (Job Duties allow for some remote work, but required to work onsite 2-3 days per week).
Seniority Level and Job Function:Mid-Senior level, Medical Equipment Manufacturing.
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