Job Description

The Senior Quality Engineer will provide Process/Quality Engineering support to manufacturing of combination medical devices, helping to ensure delivery of highest quality product to the customer. Provide Process/Quality Engineering support to product development teams, helping to ensure development of highest quality new products.

Responsibilities will include:

• Reduces and controls 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 implementing product stops & documenting release criteria.
• 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.
• May be responsible for risk analyses and FMEAs.
• 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.
• Collects and analyzes Leads Manufacturing process defect data Product/Process improvement efforts (e.g. scrap, nonconforming product, customer complaints) by systematically gathering quality metric data and performing the appropriate analysis method(s) to enhance sustaining product design and new product development
• Creates Quality Tools & Training Materials by applying body of knowledge/expertise and communicating to respective teams.
• Evaluates the adequacy and compliance of systems, operations, and practices against regulation and company documentation.
• Could serve as auditor of areas of the quality system, such as development and manufacturing, as assigned.
• Responsible for sustaining compliance and continuous improvement related to the manufacture of combination medical devices per 21 CFR part 4.
• Serve as technical lead in audits related to 21 CFR part 4 compliance.
• 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.

Required qualifications:

• 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

Preferred Qualifications:

• 7+ years of 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