Principal Quality Assurance Engineer
2 days ago
At Boston Scientific, we are seeking a highly experienced Principal Quality Assurance Engineer to join our team. This individual will be responsible for developing, establishing, and maintaining quality engineering methodologies, systems, and practices that meet BSC, customer, and regulatory requirements.
The successful candidate will serve as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals, and priorities.
This is an onsite position based in Arden Hills, MN, and the ideal candidate will have a strong background in medical device engineering and experience in product line acquisition and transfers.
Your Responsibilities Include:- Promotes Cross-Functional collaboration and has ability to influence project strategy.
- Influences and collaborates with the Product Development & Engineering team to ensure proper execution of Quality Deliverables such as project Design & Development Plans, Design Changes, and Validation Plans.
- Provides quality and manufacturing input and coaching for product and process development and product sustaining activities, such as reduction and control of Manufacturing process defects (scrap, nonconforming material, customer complaints) by leading efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions.
- May be responsible for identifying issues requiring data queries & bounding to implement complex product stops & develop release criteria.
- Develops and implements product quality plans, documents, and systems by creating product specifications, quality specifications, quality plans, risk analyses, FMEAs in conjunction with other product development team members.
- Provides project direction, coaching, and mentoring for quality engineering and technical team personnel supporting the product line(s).
- Develops solutions to complex and diverse technical problems which require the regular use of ingenuity and creativity.
- Exercises judgment within broadly defined practices and policies in selecting methods, specialized techniques, and evaluation criteria for obtaining results.
- Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.
- Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Supports internal and external regulatory audits.
- Provides technical leadership to business unit.
- Advises management on potential improvements or enhancement to quality systems and processes.
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