Manufacturing Quality Engineer - Howell, MI
About The Position
Under broad supervision, the Manufacturing Quality Engineer independently sets basic in-process quality standards and leads development of testing, sampling, and training methods. The role evaluates production processes, recommends improvements, qualifies and manages vendors, and generates and maintains Device Master Records (DMRs), product specifications, design control files, and CE technical files. The engineer manages methods and procedures for process control, validation, improvement, testing, and inspection. The role designs experiments and product tests, applies statistical process control and other statistical quality methods, analyzes reports and defective products for trends, and leads corrective actions to maintain product quality and reduce defects and failures. The position directs and collaborates with suppliers to resolve quality issues, implement corrective actions, and improve supplier quality, including leading supplier qualifications. It provides quality expertise for product development, design control, risk management, and CE technical files; supports product documentation and regulatory submissions such as 510(k) submissions and letters to file; and coordinates testing with internal and external laboratories. The engineer ensures compliance with domestic and international regulations applicable to products and processes, reviews design documentation and quality records for compliance, and leads investigations into product and process nonconformances and out-of-specification results. The role requires up to 15% travel.
Requirements
- Bachelor’s degree in Engineering, Science, Math, or another related technical field.
- At least 2 years of experience in Quality or Engineering.
- Ability to accomplish goals with little or no supervision, independently complete objectives, and determine when issues need escalation.
- Time-management skills to prioritize, organize, and track details to meet deadlines across multiple projects.
- Problem-solving experience, including overcoming obstacles and reaching successful solutions through mathematical or systematic operations.
- Experience using Microsoft Office Suite, including Word, Excel, PowerPoint, and Outlook.
- Intermediate Microsoft Excel skills, such as conditional formatting, tables, formulas, and charting.
- Working knowledge of government and industry quality assurance codes and standards, such as 21 CFR 820 and ISO 13485.
- Ability to travel up to 15%.
Nice To Haves
- At least 2 years of industry experience in medical devices, drugs, or fields directly related to the role.
Responsibilities
- Manage development and implementation of methods and procedures for process control, validation, improvement, testing, and inspection.
- Design experiments to identify sources of variation affecting products and processes.
- Apply statistical process control methods to analyze data and assess processes and process changes.
- Design and perform experimental product testing and analysis to maintain quality and minimize defects and failures.
- Generate and analyze reports and defective products to identify trends and lead corrective actions.
- Use probability and statistical quality control concepts to guide decisions.
- Work with supplier representatives to address quality problems and ensure corrective action implementation, including CAPA and SCAR.
- Contribute to supplier quality improvement programs and lead supplier qualifications.
- Provide quality expertise in product development, design control, risk management, and CE technical files.
- Build product documentation, including Device Master Records, in compliance with applicable regulations.
- Work with regulatory groups and suppliers on 510(k) submissions, letters to file, and related materials as required.
- Coordinate product testing with internal and external laboratories as required.
- Ensure compliance with domestic and international regulations associated with product lines and processes.
- Review design documentation, vendor quality documents, and company quality records for compliance with stated requirements.
- Lead investigations of product and process nonconformances and out-of-specification results, and develop effective corrective and preventive actions.
Benefits
- Competitive total rewards package.
- Continuing education and training.
- Health insurance for eligible employees working an average of 30 or more hours per week.
- Life and disability benefits for eligible employees working an average of 30 or more hours per week.
- 401(k) contributions.
- Paid time off.
- Access to the Employee Assistance Program, Employee Resource Groups, and Employee Service Corp for employees working less than 30 hours per week.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
