Quality Engineer II - Medical Device Quality & CAPA Leader

VitalPath; Fort Snelling Unorganized Territory (MN); Sur place; USD 69 000 - 87 000; Plein temps

Avantages offerts par ce poste

Health and Dental Insurance

Vision Insurance

HSA with Company Contribution

Paid Time Off

401K with Company Match

Parental Leave

Résumé du poste

VitalPath in Maplewood, MN is seeking a Quality Engineer II to provide cross-functional quality support across development and manufacturing, ensuring customer requirements are understood and properly implemented. The role focuses on non-conformance processing, CAPA, supplier control, and audits, with opportunities to advance quality systems, document control, and training for personnel.

Onsite work is required at our Maplewood facility, with a collaborative team environment and a path to grow

Qualifications

• Bachelor’s degree in engineering or related field.
• At least 3 years in a quality role in a medical device manufacturing environment.
• Experience with ISO 13485:2016 audits and QMS.

Responsabilités

• Support manufacturing, inspection, qualification, and validation of products.
• Develop and implement quality improvement with working knowledge of Quality standards and systems.
• Assures compliance of the Quality Management System (QMS), ISO 13485:2016, and customer/regulatory requirements.
• Works with customers and suppliers to resolve quality related issues.
• Support and participate in 3rd Party and customer audits, as needed.
• Work crossfunctionally on failure investigations, rootcause analysis, and corrective action implementation.
• Develop, approve, review, and updatecontrolled documents such as Procedures, Manufacturing Procedures, Work Instructions, Forms, etc.
• Train personnel, as needed, on new or updated QMS documents.
• Review and approve customer and internal drawings and specifications.
• Ensure that records are established, accurate and maintained per QMS requirements.
• Develop and implement systems for Quality and Inspection support.
• Support implementation of overall company systems that relates to Quality.
• Other duties as assigned.

Formation

Bachelor’s Degree in Engineering or related discipline

Description du poste

VitalPath in Maplewood, MN is seeking a Quality Engineer II to provide cross-functional quality support across development and manufacturing, ensuring customer requirements are understood and properly implemented. The role focuses on non-conformance processing, CAPA, supplier control, and audits, with opportunities to advance quality systems, document control, and training for personnel.

Onsite work is required at our Maplewood facility, with a collaborative team environment and a path to grow