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in Milwaukee, WI
Quality Engineer
Hours | Full-time, Part-time |
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Location | Milwaukee, Wisconsin |
About this job
Job Description
A better career for you. Creating medical technology for all.
MPE is a rapidly growing medical device manufacturer that has helped create life-enhancing technology since 1978. We value diversity, honesty, and integrity. These values are directly reflected in our everyday business practices. Our work ethic and dedication to our business partners drive us to exceed our customers’ needs and expectations.
We are looking for a Quality Engineer to monitor and improve the quality of our operational processes and outputs with applicable FDA and ISO standards.
A successful Quality Engineer should have excellent troubleshooting skills and be able to ensure that processes and products consistently meet established quality standards.
As a Quality Engineer some regular duties will be to:
- Perform and document evaluations and investigations resulting from complaints, non-conformances, and CAPA
- Deploy formal root cause analysis methods and tools during investigation
- Perform internal audits in accordance with ISO 9001 and ISO 13485 standards
- Validate and approve PAPs and NPI programs
- Author QMS documents, specifications, and work instructions that meet and maintain quality standards
Why work with MPE?
- Medical, dental, vision, short and long term disability, and life insurance the first of the month after date of hire
- 401 (K) match and profit sharing
- Vacation time given day one
- 9 Paid holidays for regular full time employees
- Paid training
- Advancement opportunities
Qualifications
- Bachelor's degree in a scientifc or engineering descipline or equivalent combination of education and experience
- 1-3 Years of experience in a Quality or Regulatory Affairs role, ideally in a GMP related industry
- Experience with quality system standards
- ASQ Certified Quality Engineer or ASQ Certified Quality Auditor preferred
- Knowledge of FDA, GMP, ISO 9001 and ISO 13485 preferred
No work sponsorship is available for this position.
No relocation is offered for this position.