What are the responsibilities and job description for the QUALITY ENGINEER position at MarketLab?
Who We Are:
Marketlab is a market leading healthcare solutions organization specializing in the design, manufacturing, and sourcing of private label products. It’s our mission to provide our healthcare partners timely solutions with a straightforward approach based on knowing them and their work. Every day we strive to positively impact the lives of the people who in turn impact the health and wellness of our communities.
Based in Grand Rapids, Michigan, Marketlab’s success is built upon a foundation of collaboration, innovation, and the belief that every team member plays a vital role in creating an exceptional customer service experience.
POSITION SUMMARY
Skilled Quality Engineer focusing on validation, equipment qualification, process improvement, supplier quality, and risk mitigation. This role is essential for providing support to technicians and staff, enhancing infrastructure, and ensuring effective and timely engineering practices.
Responsibilities:
- Regulatory Compliance: Ensures all processes and products comply with relevant regulatory standards (such as FDA, ISO 13485) and quality system requirements, documenting necessary procedures.
- Quality Control and Assurance: Designs, implements, and oversees quality control tests, including inspections, audits, and validations, to identify product defects or process inconsistencies.
- Risk Management: Conducts risk assessments (e.g., FMEA) to identify and mitigate potential failures in product design and manufacturing, ensuring patient safety and product reliability.
- Process Improvement: Analyzes quality data to identify trends, implement corrective and preventive actions (CAPA), and optimize manufacturing processes for enhanced quality and efficiency.
- Supplier Quality Management: Collaborates with suppliers to ensure incoming materials meet required specifications and participates in supplier audits and performance assessments.
- Documentation and Reporting: Maintains thorough documentation of quality activities, including test results, audit findings, and corrective actions, to support compliance and traceability.
- Cross-Functional Collaboration: Works closely with product development, manufacturing, and regulatory teams to resolve quality issues, support product development, and ensure smooth transitions from design to production.
- Customer Feedback and Complaints Handling: Reviews and addresses customer complaints and feedback, investigating issues, implementing corrective actions, and improving overall customer satisfaction.
Education and Experience:
- Bachelor’s degree in engineering or other relevant field required
- Experience with medical device manufacturing and supply chain
- Experience with ISO 14971 Risk Management for Medical Devices
