Global Sr. Quality Assurance Engineer

Nextern; Maple Grove (MN); On-site; USD 100,000 - 135,000; Full time

Benefits offered by this job

Health Plan (Medical, Dental & Vision)

Retirement Plan with Company Match

Paid Time Off, Personal Days, Birthday

Lifetime Membership Subsidy and WELL/}

Job summary

Nextern is seeking a Quality Engineer to oversee manufacturing and device quality for commercial devices at its global sites. The role focuses on sustaining activities, changes, audits, CAPAs, and complaint investigations under GMP/GDP and ISO 13485 frameworks.

Based on our Minnesota facility, the position requires hands-on quality leadership across global sites, collaboration with sustaining engineers, and proactive process improvements to ensure compliance and product quality throughout the

Qualifications

• 5+ years in medical device manufacturing quality
• Experience supporting global sites
• Compliance with 21 CFR 820 and ISO 13485
• Fluency with electromechanical terminology
• Understanding of ISO 14971 and risk management
• GMP, GDP expertise
• Leadership in quality and problem solving
• Strong communication and analytical skills
• Familiar with QC tools: nonconformance, CAPA, root cause
• Proficient with Minitab and PLM software

Responsibilities

• On-site at US facility, supporting Vietnam/Costa Rica sites up to 20%
• Receive, investigate and trend complaints
• Lead nonconformance investigations and CAPAs
• Summarize and present data to stakeholders
• Collaborate with sustaining engineers for improvements and audits
• Draft and approve project deliverables and work orders
• Review changes to parts and documentation
• Coordinate shipments between sites and customers
• Coordinate verification/validation testing
• Create and maintain Device Master Records (DMR)
• Own manufacturing/DHR review in root cause investigations
• Lead GMP/GDP practices
• Identify improvements in Quality System requirements
• Approve changes with documented impact and actions
• Support audits as SME for QMS processes
• Lead PLM architecture changes as needed

Skills

Quality experience

Global manufacturing

Regulatory compliance

GMP/GDP

Risk management

Leadership

Communication

Quality tools

Minitab

MS Office

PLM software

Windchill

Agile PLM

Propel

Electrical concepts

Education

Bachelor's Degree in engineering

Tools

Windchill

Agile PLM

Propel

Minitab

MS Office

Job description

Please note - No sponsorship or transfer of sponsorship is available for this role, including but not limited to OPT and H-1B

At Nextern, we inspire with passion, impact with significance, and act with integrity. Nextern partners with OEMs, clinicians, and innovators to design, develop, and manufacture world-class medical devices across the full product lifecycle. From single-use disposables to fully integrated systems to precision components, our teams work as an extension of yours to solve patient needs and improve lives worldwide.

This role is responsible for manufacturing and device quality for commercial devices produced at Nextern's global manufacturing sites. Quality assurance engineers own sustaining activities for investigational and commercial device manufacturing, such as changes, audits, nonconformances, CAPAs, and complaint investigations ensuring timely completion of activities. All engineering functions are responsible for compliance with the Quality System and relevant regulations and standards, continuous improvement, and as needed, professional interaction with Nextern Customers.

RESPONSIBILITIES

• Works on-site in US facility, primarily supporting Vietnam manufacturing site. and Costa Rica site support up to 20%
• Receive, open, investigate and trend complaints
• Identify, 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, and approve project deliverables and engineering work orders
• Review, collaborate on, and approve changes to parts and documentation
• Facilitate shipments between manufacturing site and customer
• Coordinate and execute, as necessary, process output testing (verification/validation)
• Create and maintain up-to-date product Device Master Records (DMR)
• Own manufacturing/DHR review as part of root cause investigations
• Lead by example in Good Manufacturing Practices (GMP) and Good Documentation Practices (GMP)
• Proactively identify redundancy and opportunities for improvement in Quality System requirements
• Own, review, and approve changes ensuring impacts and resulting action/implementation (or lack thereof) are properly documented and executed
• Support audits as Subject Matter Expert (SME) for QMS processes and product line manufacturing
• Lead Product Lifecycle Management (PLM) architecture and changes, as needed

QUALIFICATIONS

Required:

• Bachelor's Degree (BS) in engineering discipline
• 5+ years of experience in medical device manufacturing quality role
• Experience supporting global manufacturing sites
• Success working in quality systems as defined in 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, 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.
• Instinctual capability for creative thinking and proposing novel solutions
• Strong ability to communicate (written and verbally) within and across disciplines and organization structures.
• Demonstrated use of quality tools and methodologies (e.g. nonconformance, CAPAs, root cause analysis, etc..
• Familiarity with common statistical software, such as Minitab
• Experience with Product Lifecycle Management (PLM) software (e.g Windchill, Agile, Propel)
• Intermediate to advanced proficiency with MS Office Suit (Word, Excel, PowerPoint, Project, Outlook).

Preferred:

• Secondary certification in Quality (e.g. CQE, CQA) or lean (e.g. six sigma) principles preferred

Salary range: $100,000 to $135,000 depending on skills and experience

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan with Company Match
• Paid Time Off, Personal Days, AND Birthday Holiday!
• Lifetime Membership Subsidy and Wellness Resources
• Life Insurance (Basic, Voluntary & AD&D)
• Family Leave (Maternity, Paternity)
• Short-Term & Long-Term Disability
• Taco Thursdays!!!

Nexternis an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences, and we are committed to fostering an inclusive and diverse workplace. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.