Quality Engineer

Pharmavise Corporation•Maple Grove, MN

63d•Remote

About The Position

We are seeking a talented and self-driven Quality Engineer to ensure all products, processes, and quality systems within the organization comply with applicable medical device regulations and global standards. This role is integral to driving quality excellence across the product lifecycle from design and development through manufacturing, validation, and post-market support. The ideal candidate possesses a strong technical foundation, meticulous attention to detail, and a proactive approach to problem-solving and continuous improvement. This individual will collaborate cross-functionally with R&D, Manufacturing, Regulatory, and Supplier Quality teams to uphold the highest levels of product safety, compliance, and performance.

Requirements

Bachelor’s degree in Engineering, Biomedical Engineering, Mechanical Engineering, or a related scientific discipline.
Experience in a regulated medical device environment with working knowledge of FDA QSR, ISO 13485, and ISO 14971.
Hands-on experience in process validation, CAPA, risk management, nonconformance investigations, and audit support.
Familiarity with statistical analysis tools and data-driven quality decision-making.
Strong communication, documentation, and cross-functional collaboration skills.

Nice To Haves

Certification in Lean Six Sigma, ASQ CQE, or a similar credential preferred.
Working knowledge of MDSAP, EU MDR, and other international regulatory frameworks.
Proficiency with electronic QMS platforms (e.g., MasterControl, TrackWise, Veeva).
Experience with combination products, sterilization validation, or cleanroom manufacturing environments.

Responsibilities

Support design control activities, ensuring design inputs, outputs, verification, and validation meet regulatory and organizational requirements.
Participate in risk management activities (ISO 14971), including FMEA and hazard analysis.
Review and maintain Design History Files (DHF), technical documentation, and change control records.
Collaborate with R&D, Manufacturing, and Regulatory teams to ensure compliant design transfer into production.
Support and lead process validation activities (IQ/OQ/PQ), ensuring adherence to validation master plans.
Evaluate nonconformances and conduct root cause investigations using structured problem-solving tools (5 Whys, Fishbone, etc.).
Drive Corrective and Preventive Actions (CAPA) to timely closure and verify effectiveness.
Monitor production processes and quality metrics, identifying trends and improvement opportunities.
Support equipment qualification, calibration, and validation maintenance to ensure compliance.
Participate in supplier qualification, performance monitoring, and audits to verify compliance with quality requirements.
Manage Supplier Corrective Action Requests (SCARs) and collaborate with suppliers to resolve quality issues.
Review incoming inspection results, PPAP documentation, and supplier process records.
Maintain and continuously improve the Quality Management System (QMS) in compliance with 21 CFR Part 820, ISO 13485, MDSAP, and EU MDR.
Prepare for and support internal, external, and regulatory audits, including documentation and response management.
Create, revise, and implement Standard Operating Procedures (SOPs) and work instructions.
Participate in change control reviews to ensure ongoing product and process compliance.
Utilize data analysis and statistical tools (SPC, Cpk, Minitab, etc.) to drive process and product improvements.
Apply Lean Six Sigma methodologies to enhance efficiency and reduce waste.
Contribute to cross-functional projects focused on risk mitigation and operational excellence.
Support training and mentoring of cross-functional teams on quality principles, tools, and regulatory expectations.