Quality Engineer

Pay: $75,000.00 – $90,000.00 per year

Job description:

1.0 PURPOSE

• Complete quality engineering initiatives to support Engineering, Manufacturing, and all other departments to improve measurement, detection, and prevention of quality issues.
• Use structured problem-solving methodologies across departments to analyze and provide root cause analysis.
• Help drive continuous improvement initiatives to minimize process variation, scrap, and Cost of Poor Quality (COPQ) through proactive analysis and lean principles.

2.0 RESPONSIBILITIES / AUTHORITY

• Serve as a key technical liaison with customers to address quality concerns, manage complaint resolution, and ensure timely, data-driven responses to issues affecting product performance or compliance.

..1 Use structured problem-solving techniques to converge on root cause

..2 Ensure changes put in place are effective at long term prevention

..3 Measure effectiveness

..4 Teach techniques and staff to eliminate problems

• Provide analysis, support, and lead measurement efforts and establishment of control plans and methodologies for new products during development and launch process working with Engineering program managers.

..1 Create measurement programs, Keyence, CT Scanner, OGP

..2 Create templates in ERP for inspection

..3 Design process to be used by floor inspectors, operators, QA techs

..4 Design gauges when necessary

• Research and recommend next generation of measurement methods, technology, and automation; to improve accuracy and consistency and increase the number of parts we can analyze for both metrology and production departments.
• Evaluate product and process changes, recommend quality improvements, and enforce adherence to internal standards and customer requirements throughout the product lifecycle.

3.0 DUTIES

• Develop a strong working knowledge of precision measurement equipment (e.g., CMMs, vision systems, etc.) to measure parts, write programs, provide technical guidance, support troubleshooting, and provide hands on training for QC Inspectors and metrologists in proper operation, programming and best practices.
• Provide all QC inspection personnel (dimensional and visual inspections) with clarification to questions on parts and equipment.
• Direct, design and develop custom mechanical or electromechanical fixtures, gauges, and tools to streamline inspection processes and enable effective use by QC technicians and/or shop floor operators.
• Direct effective implementation and long-term sustainability of root cause corrective actions and continuous improvement initiatives, in alignment with the company’s and departments, and customer quality requirements.
• Procure or assist in the selection, specification, ordering, and implementation of quality-related equipment, inspection systems, and facility improvements that support enhanced product quality, process control, automation, productivity, and regulatory compliance.
• Measure and inspect parts when needed to support Engineering, Metrology, or Quality groups and the company.

4.0 EDUCATION

• ASME, BSME, or other technical degree preferred.
• Alternatively, a degree in a closely related technical discipline that emphasizes analytical thinking, design principles, and structured problem solving.
• Lean/Six Sigma Black Belt certification, CQE, a plus.

5.0 EXPERIENCE

• 7-10 years of industry experience with a minimum of 3-5 years of QE experience.
• Structured root cause analysis and problem solving, ideally within the medical device components industry or a similarly regulated manufacturing environment. Experience with ISO 13485:2016 a plus.
• Proficient in statistical analysis tools and techniques; experience with Minitab, SPC methods.
• Strong experience in interpreting engineering drawings and specifications, with proficiency in GD&T; familiarity with injection molding processes is a plus.
• Proficient in SolidWorks, with demonstrated ability to design fixtures, inspection tooling, and quality-related mechanical components;
• Proficiency in Microsoft Excel for data analysis, reporting, and visualization; working knowledge of other Microsoft Office tools including Word, PowerPoint, and MS Project.

6.0 PERSONAL CHARACTERISTICS

• Excellent written and verbal communication skills, with the ability to clearly convey technical information across all levels of the organization and to external stakeholders.
• Strong team building and leadership traits fosters collaboration, motivates others, and contributes positively to team dynamics and shared goals.
• Highly organized, dependable, and detail-oriented, with an initiative-taking approach to managing tasks and delivering high-quality work.
• Demonstrates a consistently positive attitude, professionalism, and integrity; serves as a role model for company culture through strong character and respectful engagement.
• Maintains a high level of accuracy and attention to detail in documentation, analysis, and execution of quality-related activities.

7.0 REPORTING RELATIONSHIP

• Reports to Vice President

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Professional development assistance
• Retirement plan
• Tuition reimbursement
• Vision insurance

Work Location: In person