Quality Engineer Jobs

About The Position

Requirements

• Bachelor’s degree in an engineering discipline.
• At least 5 years of experience in a medical device manufacturing quality role.
• Experience supporting global manufacturing sites.
• Experience working in quality systems defined by 21 CFR 820 and ISO 13485.
• Fluency in electromechanical terminology and component naming conventions and functions.
• Basic understanding of electrical engineering principles and electrical diagnostic techniques.
• Expert-level knowledge and application of GMP and GDP.
• Understanding of ISO 14971 and application of risk management principles.
• Demonstrated technical expertise and leadership in quality.
• High attention to detail, organization, and accuracy.
• Ability to think creatively and propose novel solutions.
• Strong written and verbal communication skills across disciplines and organizational structures.
• Demonstrated use of quality tools and methodologies, such as nonconformance, CAPAs, and root cause analysis.
• Familiarity with common statistical software, such as Minitab.
• Experience with PLM software, such as Windchill, Agile, or Propel.
• Intermediate to advanced proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, Project, and Outlook.

Nice To Haves

• Secondary certification in Quality, such as CQE or CQA.
• Knowledge of lean principles, such as Six Sigma.

Responsibilities

• Receive, open, investigate, and trend complaints.
• Own and execute nonconformance investigations and CAPAs.
• Compile, summarize, and present manufacturing and performance data internally and to customers.
• Partner with sustaining engineers to implement changes, drive improvements, and facilitate audits.
• Draft, collaborate on, and approve project deliverables and engineering work orders.
• Review, collaborate on, and approve changes to parts and documentation.
• Facilitate shipments between manufacturing sites and customers.
• Coordinate and execute process output testing, including verification and validation, as necessary.
• Create and maintain current product Device Master Records (DMRs).
• Own manufacturing/DHR review as part of root cause investigations.
• Lead by example in Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
• Identify redundancies and opportunities to improve Quality System requirements.
• Own, review, and approve changes, ensuring impacts and resulting actions or decisions not to act are properly documented and executed.
• Support audits as a subject matter expert for QMS processes and product-line manufacturing.
• Lead Product Lifecycle Management (PLM) architecture and changes, as needed.

Benefits

• Health care plan covering medical, dental, and vision.
• Retirement plan with company match.
• Paid time off and personal days.
• Birthday holiday.
• Lifetime membership subsidy and wellness resources.
• Life insurance, including basic, voluntary, and AD&D coverage.
• Family leave, including maternity and paternity leave.
• Short-term and long-term disability coverage.
• Taco Thursdays.