Quality Engineer - P1 at Boston Scientific
Additional Locations: N/A
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
Purpose Statement
* Demonstrating and promoting a commitment to improving patient safety, customer satisfaction and product quality in BSC.
* Understanding and complying to BSC’s quality, business, health & safety systems and market/legal regulations governing the quality systems.
* Removing or mitigating against risks associated with the design, use and manufacture of BSC devices.
* Ensuring commitment to training requirements and understanding and complying with all regulations governing their work.
Key Responsibilities
General
* Completes work assignments under limited supervision/guidance.
* Interfaces with R&D, Regulatory Affairs, Clinical, Medical Safety, Complaints Management Centres and Post Market Quality Assurance team environment providing technical and quality systems input.
* Familiarity with requirements and procedures that govern medical device Design Control, Risk Management and Post Market Surveillance.
* Seeks to support improvements in product and process quality.
* Builds Quality into all aspects of work by maintaining compliance to all quality requirements.
* Excellent interpersonal and communication skills with good leadership abilities.
Technical
* Provides both quality and technical input to ongoing product development, product sustaining and post-market commercial product activities.
* Experienced in post-market (complaints) support, risk management, design and process change, standards compliance (to regulatory requirements).
* Provides design quality support in the resolution of PIRs, complaints investigation, CAPAs, VIPs, and regulatory requirement changes.
* Analytical and problem‑solving abilities. Analyses, draws conclusions and makes appropriate decisions from risk management activities and test data.
Education
* Minimum of Bachelor of Science Degree Level 8 in Engineering/Technology.
* 1/2 years’ experience in a manufacturing environment or equivalent with direct experience in a QA environment (preferably GMP regulated).
* Experience in the medical device industry is an advantage.
Requisition ID: 615509
Seniority level
Not Applicable
Employment type
Full-time
Job function
Other
Industries
Medical Equipment Manufacturing
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