Senior Quality Engineer - Combination Device

Boston Scientific • Arden Hills, MN

1d

About The Position

Provide Process/Quality Engineering support to product development teams, helping to ensure development of highest quality new products. Your responsibilities will include: Develops and implements product quality plans, documents and systems by creating product specifications, quality specifications, quality plans, risk analysis, FMEAs in conjunction with other product development team members. Develops and implements Process Monitoring Systems by identifying critical process steps which could culminate in possible sources of manufacturing defects and devising methods to reduce process variation in order to reduce/eliminate the cause of defects. Evaluates the adequacy and compliance of systems, operations, and practices against regulation and company documentation. Responsible for sustaining compliance and continuous improvement related to the manufacture of combination medical devices per 21 CFR part 4. Responsible for performing appropriate analysis to identify trends, improvement opportunities, and/or corrective actions related to combination medical devices per 21 CFR Part 4. Responsible for the final Process Monitor Release for products prior to distribution.

Requirements

• Bachelor's degree in chemical engineering, chemistry or related field
• Minimum of 5 years of relevant manufacturing experience
• Regulated industry experience
• Knowledge and ability to use statistical methods such as trend analysis, pareto and other charting techniques
• 7+ years relevant experience with 2 of those years as technical leadership experience
• Strong verbal, written communication skills, both technical and conversational
• Decision making and negotiation skills, individually and within groups
• Experience in managing multiple projects across multiple organizational disciplines
• Experience in 21 CFR Part 4, cGMP compliance for drug combination medical devices
• Audit experience as a technical lead

Responsibilities

• Develops and implements product quality plans, documents and systems by creating product specifications, quality specifications, quality plans, risk analysis, FMEAs in conjunction with other product development team members.
• Develops and implements Process Monitoring Systems by identifying critical process steps which could culminate in possible sources of manufacturing defects and devising methods to reduce process variation in order to reduce/eliminate the cause of defects.
• Evaluates the adequacy and compliance of systems, operations, and practices against regulation and company documentation.
• Responsible for sustaining compliance and continuous improvement related to the manufacture of combination medical devices per 21 CFR part 4.
• Responsible for performing appropriate analysis to identify trends, improvement opportunities, and/or corrective actions related to combination medical devices per 21 CFR Part 4.
• Responsible for the final Process Monitor Release for products prior to distribution.

What This Job Offers

• Career Level: Mid Level