Quality Engineer III
About The Position
Cretex Medical is a contract manufacturer of precision components and assemblies for the medical device industry, including injection molding, laser processing, metal stamping, and device assembly. The Quality Engineer III provides quality assurance support for manufacturing and is responsible for defining, implementing, and improving quality practices. The position also provides technical guidance and support for measurement methodologies. The role supports manufacturing and project management, develops inspection requirements, facilitates PFMEAs, resolves discrepant material issues, and creates and maintains quality documents such as control plans and inspection plans. The Quality Engineer analyzes data to identify improvement opportunities and serves as the quality interface for a production team responding to customer complaints through failure analysis, corrective and preventive actions, and trend analysis. The position conducts audits, addresses audit findings, supports process, equipment, and metrology validation, and creates protocols and analyzes data. The Quality Engineer III supports and mentors Quality Engineers I and II, serves as a subject matter expert in one or more areas of the ASQ Quality Engineering Body of Knowledge, and leads or participates in large company projects by providing quality recommendations. The role works with Quality Inspectors to ensure inspection plans meet customer product requirements and partners with sales and marketing, customer service, engineering, quality, and finance. It also supports the company Quality System, ISO, and medical device requirements, business systems, and the Operational Excellence Program. The role requires working in a manufacturing environment.
Requirements
- Bachelor’s degree in Mechanical Engineering, Industrial Engineering, or another engineering science.
- Six years of engineering experience in a machining or manufacturing setting.
- Knowledge of quality systems, regulatory requirements, and industry standards.
- Advanced blueprint-reading and GD&T knowledge.
- Ability to operate and train others on a variety of inspection equipment.
- Statistical expertise with DOE and capability studies.
- Experience with Minitab.
- Process management skills.
- Ability to consistently achieve short- and long-term business results.
- Experience with ERP and quality systems.
- Proficiency with Microsoft Office, including Outlook, Word, Excel, PowerPoint, and Publisher.
- Clear and effective verbal and written communication skills.
- Attention to detail and organizational skills.
- Ability to work in a fast-paced team environment and prioritize and multitask.
- Ability to work in a manufacturing environment.
Nice To Haves
- Experience in injection molding.
- Experience in the medical device industry.
Responsibilities
- Provide quality engineering support for manufacturing and project management.
- Develop inspection requirements, facilitate PFMEAs, resolve discrepant material issues, and create and maintain control plans, inspection plans, and other quality documents.
- Analyze data and identify improvement opportunities.
- Serve as the quality interface for a production team responding to customer complaints through failure analysis, corrective and preventive actions, and trend analysis.
- Conduct audits, close out audit findings, create audit finding reports, and determine appropriate corrective and preventive actions.
- Coach and mentor Quality Engineer levels I and II.
- Serve as a subject matter expert in one or more areas of the ASQ Quality Engineering Body of Knowledge.
- Lead and participate in large company projects, providing quality recommendations.
- Support Quality Inspectors in ensuring inspection plans comply with customer product requirements.
- Support validation activities for processes, equipment, and metrology; create protocols and analyze data.
- Ensure business systems are implemented, maintained, and functioning properly.
- Support and comply with the company Quality System, ISO, and medical device requirements.
- Read, understand, and follow work instructions and standard work.
- Partner with sales and marketing, customer service, engineering, quality, and finance.
- Understand customer needs and the core business markets served.
- Participate in required company meetings and the Operational Excellence Program.
- Maintain an organized work area using 5S.
- Complete other work duties as assigned.
Benefits
- 401(k) retirement savings plan with company match.
- Onsite health clinics.
- Discretionary holiday bonus program based on years of service.
- Cretex University.
- 24/7 employee assistance program, including access to five confidential visits with a licensed counselor at no cost.
- Wellness program with incentives.
- Employee death benefit.
- Employee sick and safe leave.
- For employees working 20 or more hours per week: medical insurance with access to virtual providers, dental insurance, vision insurance, a pre-tax health savings account, healthcare and dependent-care pre-tax reimbursement accounts, paid holidays, paid time off, and discretionary profit sharing.
- For employees working 30 or more hours per week: parental leave, accident and critical illness benefits, optional employee, spouse, and child life insurance, short- and long-term disability, company-provided life insurance, and tuition assistance.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
