Are you looking for an opportunity to join a global team recognized for leadership, innovation, and diversity? If so, there has never been a more exciting time to work for Creative Foam Medical Manufacturing!
We have an amazing opportunity as Quality/Regulatory Engineer. This position will be responsible for providing quality and regulatory support to the operations teams, specifically as it relates to ISO 13485:2016, and FDA. S/He will provide direction, training, and guidance to the quality team, assist management in decision making, collect and analyze data, and present knowledge to improve Creative Foams overall QMS.
Key responsibilities include:
- Develop and implement ISO 13458:2016 quality standards.
- Develop and implement quality control systems.
- Monitor and analyze quality performance throughout multiple facilities.
- Manage internal audits as Lead Auditor
- Inspect and test materials, equipment, processes, and products to ensure quality specifications are met.
- Collaborate with operations managers to develop and implement controls and improvements.
- Ensure that workflows, processes, and products comply with safety regulations.
- Investigate and troubleshoot product or production issues.
- Develop corrective actions, solutions, and improvements.
- Review codes, specifications, and processes.
- Provide training and education to facility employees regarding the Quality Management System.
- Support verification and validation efforts.
Qualifications – (Desirable):
- Four-year technical degree in quality, industrial, or mechanical engineering
- 2+ years of experience in quality engineering, quality assurance, or a similar role.
Knowledge, Skills & Experience (Essential):
- ISO 13485:2016
- Experience working in manufacturing environment
Knowledge, Skills & Experience (Desirable):
- EU MD
- Bi-lingual; English and Spanish a plus
- Lead Auditor Trained
- ASQ certification a plus.
- Experience coding and using QA software tools and processes.
About Creative Foam:
Since 1969, Creative Foam has been a leading supplier of cellular and non-cellular foam and plastic products for customers in the automotive, medical and composite markets. We have manufacturing locations in Michigan, Indiana, Ohio, Colorado and Tennessee. Our longevity and success are attributable to our innovative people, an abiding passion for quality and an unwavering commitment to our customers.
Creative Foam offers a comprehensive compensation and benefits plan, including medical, dental, vision, 401(k) and tuition reimbursement.