Responsibilities
- Apply expertise in design controls and quality engineering to influence new product development, including customer feedback integration, design input/output definition, verification and validation, process validation, component qualification, and risk assessment.
- Guide and support junior quality engineers and technicians in their professional growth.
- Lead and coordinate quality management activities within projects.
- Actively participate in early product development phases, including interactions with physicians, component design, competitive analysis, and prototype evaluation.
- Collaborate with product engineering teams to define quality standards and validation requirements for parts, subassemblies, and final products.
- Ensure all product development processes comply with ISO standards and internal quality system protocols.
- Promote predictive engineering practices, including reliability and capability assessments, in both design and manufacturing.
- Provide quality assurance support to resolve defects and ensure products meet specifications.
- Document test outcomes and recommend improvements based on data analysis and product quality trends.
- Support the creation, refinement, and execution of QA testing procedures and reporting systems.
- Define and track quality metrics to proactively identify and prevent potential issues.
- Oversee and coordinate testing activities across multiple projects and tasks.
- Train and mentor QA and QC personnel to enhance team capabilities.
- Develop and maintain standardized methods for inspection, testing, and evaluation of components and products.
- Investigate quality failures, determine root causes, analyze data, and implement corrective actions.
- Conduct process capability and special studies to improve process control and reduce quality-related costs.
- Plan and supervise product inspections, design reviews, and testing to ensure part and product quality.
- Review design documentation for compliance with regulatory and company quality requirements, including vendor manuals and internal records.
- Operate precision measurement tools such as calipers, micrometers, Rockwell hardness testers, surface plates, optical comparators, and CMMs.
- Demonstrate strong understanding and application of geometric dimensioning and tolerancing (GD&T).
- Support ongoing compliance with ISO 9001 quality management standards.
- Collaborate with manufacturing and warehouse supervisors to meet inspection and quality needs.
- Lead and manage the company's corrective action program.
- Ensure high-quality, consistent products are successfully introduced to the market.
- Perform additional duties as assigned.
Work Arrangement
On-site
Working Conditions
Work typically takes place in a climate-controlled office and within a heated manufacturing and warehouse setting. Exposure to extreme temperatures, poor ventilation, fumes, and gases is minimal. Noise levels are moderate, consisting of light manufacturing, shipping/receiving activity, and standard office equipment. No significant environmental hazards are present during normal job functions.
Physical Demands
The role requires the ability to lift items up to 35 pounds, move objects as needed, and perform lifting, pushing, and pulling tasks. Employees may need to stand and walk throughout the day, operate hand tools, and occasionally bend, stoop, kneel, or crouch. Accommodations can be made for individuals with disabilities to perform essential job functions.
Other
- Ability to lift objects up to 35 lbs.
- Capable of moving objects as required.
- Able to lift, push, and pull items as necessary.
- May need to stand and walk for extended periods.
- May be required to use small hand tools.
- Occasional bending, stooping, kneeling, and crouching may be necessary.
