Quality Engineer
About our environment
- GMI Solutions is a well established contract manufacturer established in 1983.
- Team and family oriented philosophy throughout.
- Plenty of on-site amenities and special events.
Position Summary
The Quality Engineer will play a critical role in ensuring the highest quality standards for our electro-mechanical subassemblies used in medical devices and other applications. This position involves supporting the efforts to develop, implement, and maintain quality systems and procedures to ensure compliance with industry standards and regulatory requirements. The Quality Engineer will work closely with cross-functional teams to identify and resolve quality issues, drive continuous improvement, and support product development and manufacturing processes.
Essentials Duties and Responsibilities:
This list of duties and responsibilities is not all inclusive and may be expanded to include other duties and responsibilities as management may deem necessary to meet the needs of the organization from time to time, as needed.
- Support the development, implementation, and maintenance of quality systems, controls, and procedures in compliance with ISO 13485 and other relevant standards and regulations.
- Conduct root cause analysis and implement corrective and preventive actions (CAPA) for quality issues.
- Perform inspections, testing, and audits of incoming materials, in-process components, and finished products to ensure they meet quality standards and specifications.
- Collaborate with engineering, production, and sourcing teams to ensure quality requirements are met throughout the product lifecycle.
- Participate in design reviews, process validation, and risk assessments to ensure quality considerations are integrated into product development and manufacturing processes.
- Support the engineering transfer of new projects to production.
- Perform first article inspections on components and final assemblies.
- Support installation qualification, operational qualification, and performance qualification (IQ/OQ/PQ) efforts.
- Handle internal calibration efforts and coordinate external calibration needs.
- Support the development and maintenance of quality metrics and key performance indicators (KPIs) to monitor and improve quality performance.
- Provide training and support to staff on quality systems, procedures, and best practices.
- Interface with customers, suppliers, and regulatory agencies on quality-related matters.
- Lead and participate in continuous improvement initiatives to enhance product quality, reduce defects, and improve overall efficiency.
Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Requires an Associate or Bachelor’s degree in Industrial, Electric, Mechanical, or Quality Engineering, preferably with demonstrable directly applicable job experience.
Knowledge, skills and abilities required
Experience in problem solving, analytical skills, and root cause analysis, including Six Sigma practices, with the ability to clearly communicate and share solutions with cross-functional teams, suppliers, and customers.
- Familiarity and functional knowledge of an ISO 9000-based quality system. This knowledge and experience should include design, purchasing and supplier management, calibration, corrective action (both internal and supplier), non-conforming product, inspection, quality auditing, and software validation practices.
- Must be able to develop procedures and work instructions to define and support operational processes and quality system compliance.
- Knowledge of various computer software, specifically in areas of quality engineering, Microsoft Office, databases, data collection, and trend analyses. Strong knowledge of Microsoft Excel is required.
- Must be able to handle multiple tasks at once, be self-motivated, work independently, adjust to changing priorities, and clearly communicate, both written and verbally, with others, including customers and vendors. Must also provide comprehensive report summaries from collected data.
- Familiarity and functional knowledge of ERP/MRP and/or PLM systems, and lean manufacturing practices.
Physical requirements and working conditions
The physical demands described here are representative of those that must be met by an associate to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The phrases “occasionally,” “regularly,” and “frequently” correspond to the following definitions: “Occasionally” means up to 1/3 of working time, “regularly” means between 1/3 and 2/3 of working time, and “frequently” means 2/3 and more working time.
While performing the duties and responsibilities of this position, the Associate is frequently required to stand and use hand(s) to operate tools and assemble parts. The Associate must possess mobility to be able to work in a standard office and manufacturing setting and ESD manufacturing work environment and be able to use standard office equipment, including a computer and quality/ manufacturing equipment such as inspection tools and test equipment. The Associate will occasionally talk and listen, climb or balance, reach above shoulders, bend at the knees or waist. H/she will frequently sit, walk, use hands to finger, handle or touch, stoop, kneel, and move from place to place. The Associate will occasionally lift and carry materials weighing up to 90 pounds. Specific vision requirements for this position include ability to read printed materials and a computer screen. H/she must be able to effectively communicate in person and over the telephone.
This position is factory based, in Mequon, WI.
The Cherries on Top:
GMI offers a competitive compensation and benefits package that includes:
- Compensation with Annual Profit Sharing
- 401k plan with company match
- Paid Vacation, Holidays, plus 2 personal days annually
- Generous Employee Referral program
- Corporate sponsored Luncheons and Happy Hours
- Company Events, Competitions and Group Volunteer Opportunities
We’re a medium size, family-oriented company that values our associates and are looking for your help to make a difference to the company’s overall success.
If this sounds interesting, we want to hear from you!
If you have questions, feel free to email us at work4us@gmisolutions.com
Revised 07/25/2024