An opportunity to join an established and specialized Medical Devices manufacturer who have been in the area for more than 3 decades, going through a period of expansion due to customer delivery success. Part of the engineering side of the experienced quality team lead my an industry leader, you'll have the chance to implement your own ideas on how quality should operate!
- Initiating and consulting in the development and updating of Risk Management FMEA documentation in cooperation with cross-functional engineering teams per project requirements.
- Taking the lead on Quality Engineering support for certain medical device products
- Applying knowledge of design control principles, statistics, process & systems validation, and quality engineering techniques to positively influence projects and manufacturing.
- Conducting audits for internal manufacturing processes to ensure compliance with work instructions, summarizing findings, outlining opportunities for improvement, and proactively identifying potential non-conformances.
- Assisting in qualification activities associated with supplier/vendor design characterization requirements for projects, to include audits and assessments.
- Bachelor's in a Life Sciences discipline
- 4 years' experience in a quality related role in a regulated manufacturing environment (Medical Device, Aerospace, Defense, Pharmaceuticals)
- Strong background in root cause analysis and corrective action, identifying the problems and sorting them in a customer-focused field
- Only US Citizens and Green Card Holders can be considered at this time.
We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.
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