We are seeking a Quality Engineer III to lead quality engineering activities supporting new product development, manufacturing operations, process validation, risk management, and continuous improvement initiatives within a highly regulated medical device environment. This role serves as a technical quality leader, partnering with customers, operations, engineering, and regulatory teams to drive product quality, compliance, and process excellence.
Client Details
Our client is an industry-leading advanced manufacturing organization experiencing significant growth and investment across its operations. Known for innovation, technical excellence, and a people-focused culture, the company offers employees the opportunity to make a direct impact while working on highly complex medical technologies.
Description
- Lead quality engineering support for product development, manufacturing, and continuous improvement projects
- Drive implementation and optimization of quality systems, quality controls, and process improvements
- Facilitate risk assessments and develop risk mitigation strategies using tools such as PFMEA and risk management frameworks
- Lead root cause investigations, CAPA activities, and corrective action effectiveness reviews
- Support and execute equipment, process, and product qualification and validation activities
- Develop and maintain quality control plans, inspection strategies, and process monitoring systems
- Implement and maintain statistical process controls and sampling methodologies
- Ensure compliance with ISO 13485, FDA regulations, and internal quality standards
- Participate in technical and design reviews as the quality representative
- Serve as a subject matter expert in multiple quality disciplines
- Collaborate with customers to resolve quality concerns, complaints, and product-related issues
- Author validation protocols, reports, process deviations, and change notifications
- Support manufacturing troubleshooting and process optimization activities
- Develop, implement, and maintain metrology equipment and measurement systems
- Conduct Gage R&R studies and analyze manufacturing and validation data
- Approve nonconformance dispositions and manage quality documentation
- Develop quality procedures and provide training across the organization
- Support supplier quality activities, including audits and qualification efforts
- Act as the quality lead on cross-functional new product introduction and acceleration programs
Profile
- Bachelor's degree in Engineering or a related technical discipline
- Minimum 2+ years of Quality Engineering experience within medical device manufacturing or a regulated engineering environment
- Strong knowledge of ISO 13485 and FDA 21 CFR 820 quality system requirements
- Experience with CAPA, nonconformances, root cause investigations, and risk management processes
- Knowledge of validation and qualification methodologies for equipment, products, and manufacturing processes
- Experience developing quality documentation, procedures, protocols, and reports
- Working knowledge of statistical analysis tools and Minitab
- Strong technical writing and communication skills
- Ability to interact professionally with customers, suppliers, and cross-functional teams
- Experience with SPC, inspection planning, and quality control methodologies
- Exposure to supplier quality management and auditing is preferred
- CQE, Six Sigma Green Belt, or Belt certifications are highly desirable
- Experience mentoring team members and leading projects is a plus
Job Offer
- Permanent position.
- Salary range of $80,000 to $103,000.
- Work on innovative technologies that directly impact the medical device industry
- Join a rapidly expanding organization with strong growth opportunities
- Gain exposure to advanced manufacturing and cutting-edge engineering projects
- Take ownership of high-visibility quality initiatives and strategic programs
- Collaborate with talented technical teams in a fast-paced, innovation-driven environment
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.