Principal Quality Systems Engineer
About The Position
Your responsibilities will include: Works independently within broad guidelines and policies, receives minimal guidance Supports and provides guidance towards training, technical tools and driving continuous improvement and efficiencies to support a preventive quality culture. Provides guidance to GCE CAPA portfolio management ensuring a high-quality standard and in line with applicable Management Review metrics. Acts as a CAPA mentor for corrective actions necessary to improve the global CAPA, NCEP and PIR processes as appliable. Guide NCEP and CAPA teams, from a technical perspective, through risk assessment, correction, structured root cause analysis and corrective actions. Remains current on all quality systems regulations for all regulatory agencies related to the CAPA Pillar. Mentors Capital Equipment CAPA, NCEP and PIR Stewards to create and champion improvement in the CAPA Pillar and all related SOP's and business processes. Acts as a resource and mentor for colleagues with less experience Support and potentially lead Service Quality internal audits as needed. Provide guidance and expertise regarding audit strategies and approaches.
Requirements
- Bachelor's degree in relevant field and 7+ years CAPA/NCEP or equivalent experience
- Proven leadership success through direct or indirect supervisory experience or experience leading cross-functional teams, implementing strategies, and achieving measurable results
- Understanding of regulations and standards applicable to the BSC Global Quality System and CAPA, NCEP and PIR processes (ISO 13485, 21 CFR 820, EU MDR, etc.)
- Experience with CAPA and CAPA concepts
- Quality system experience in the medical device industry
- Strong working knowledge of FDA QSR, ISO 13485, ISO 14971, and post-market requirements.
- Strong verbal, written communication skills, both technical and conversational
- Experience supporting or leading audits and interacting with auditors as a CAPA/quality SME.
- Experience collaborating with international regions
Nice To Haves
- Master's degree in Engineering, Quality, or related technical discipline
Responsibilities
- Works independently within broad guidelines and policies, receives minimal guidance
- Supports and provides guidance towards training, technical tools and driving continuous improvement and efficiencies to support a preventive quality culture.
- Provides guidance to GCE CAPA portfolio management ensuring a high-quality standard and in line with applicable Management Review metrics.
- Acts as a CAPA mentor for corrective actions necessary to improve the global CAPA, NCEP and PIR processes as appliable.
- Guide NCEP and CAPA teams, from a technical perspective, through risk assessment, correction, structured root cause analysis and corrective actions.
- Remains current on all quality systems regulations for all regulatory agencies related to the CAPA Pillar.
- Mentors Capital Equipment CAPA, NCEP and PIR Stewards to create and champion improvement in the CAPA Pillar and all related SOP's and business processes.
- Acts as a resource and mentor for colleagues with less experience
- Support and potentially lead Service Quality internal audits as needed.
- Provide guidance and expertise regarding audit strategies and approaches.
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What This Job Offers
Career Level
Principal
