CAPA & Quality Systems Engineer

Regulatory Jobs; Golden Valley (MN); Sur place; USD 70 000 - 90 000; Plein temps

Avantages offerts par ce poste

401k plan + employer match

Tuition Reimbursement

Résumé du poste

Inspire Medical Systems is seeking a CAPA/Quality professional to lead corrective and preventive actions across internal and supplier processes. You will work with Development, Manufacturing, Marketing and IS to ensure CAPA activities align with Inspire procedures and regulatory requirements.

The role requires 2–5 years in medical device quality/design, strong leadership, and proficiency with standard MS Office tools.

Qualifications

• Bachelor’s degree in a technical or scientific field.
• Bachelor’s degree in engineering such as electrical, mechanical, materials, manufacturing or biomedical.
• Master’s degree in a technical or scientific field.
• 2 - 5 years minimum experience in quality or design function in the finished medical device industry.
• Knowledge on ISO and FDA/Quality System Requirements. (e.g. ISO 13485; ISO 14969; FDA 21 CRF Part 820, 821, 822)
• Strong project and time management skills
• Demonstrated creative and effective problem solving and original thinking for compliance solutions
• Ability to work on multiple tasks concurrently with changing priorities
• Proficient with MS Word, Excel and PowerPoint

Responsabilités

• Manage CAPA process for internal Inspire CAPAs as well as supplier corrective and preventive action requests (SCARs).
• Lead cross-functional teams to resolve quality issues and navigate the CAPA process.
• Monitor CAPA deliverables, CAPA timelines and trend both CAPAs and SCARs.
• Schedule CAPA team meetings and monthly CAPA management reviews.
• Report on CAPA progress at monthly CAPA meetings as well as Quality management reviews.
• Support CAPA activity, including CAPA owner assignment, root cause tools and verification of effectiveness checks.
• Partner with Inspire product quality and manufacturing teams to support supplier corrective actions.
• Provide audit support for CAPA and SCAR processes.
• Partner with Material Quality to develop SCAR timelines and process monitors.
• Support non-conformance (NCR) process and process trending.
• Participate in the development of quality work instruction and procedural updates as assigned.

Connaissances

Team leadership

Project management

Time management

Problem solving

Communication

Formation

Bachelor’s degree in a technical or scientific field

Bachelor’s degree in engineering

Master’s degree in a technical or scientific field

Outils

MS Word

Excel

PowerPoint

Description du poste

Inspire Medical Systems is seeking a CAPA/Quality professional to lead corrective and preventive actions across internal and supplier processes. You will work with Development, Manufacturing, Marketing and IS to ensure CAPA activities align with Inspire procedures and regulatory requirements.

The role requires 2–5 years in medical device quality/design, strong leadership, and proficiency with standard MS Office tools.