Senior MedTech Quality Engineer - CAPA & Compliance

Planet Pharma; Eagan (MN); On-site; USD 100,000 - 135,000; Full time

Job summary

Planet Pharma seeks a Sr. Quality Engineer to develop and maintain quality engineering methodologies for medical devices. You will drive quality improvements for New Product Introductions, transfers, and market support, providing systematic problem-solving and CAPA leadership.

Responsibilities include reviewing documentation, supporting audits by FDA/Notified Bodies, and guiding sterilization and cleanroom testing. Strong English communication is required.

Qualifications

• Bachelor’s Degree in a technical or scientific discipline.
• Minimum 8 years of experience in a medical device design and manufacturing environment.
• Strong knowledge of FDA 21 CFR Regulations, ISO 13485, Health Canada Regulations, EU Medical Device Regulations, ISO 14971.
• Excellent verbal and written communication skills in English.

Responsibilities

• Follow all regulations, standards, procedures, and work instructions defined in the Quality System Manual.
• Manage product sterilization, product testing and control environment/cleanroom testing guidance.
• Lead CAPA investigations and document deviations.
• Review and release sterile product; update procedures and labels.
• Support inspections/audits by Customers, FDA, Notified Bodies, OSHA.

Skills

Inspection principles

Validation principles

Analytical problem solving

CAPA management

Documentation processes

Education

Bachelor’s Degree in technical/scientific discipline

Tools

Word

Excel

Adobe Acrobat

LabelView

Job description

Planet Pharma seeks a Sr. Quality Engineer to develop and maintain quality engineering methodologies for medical devices. You will drive quality improvements for New Product Introductions, transfers, and market support, providing systematic problem-solving and CAPA leadership.

Responsibilities include reviewing documentation, supporting audits by FDA/Notified Bodies, and guiding sterilization and cleanroom testing. Strong English communication is required.