Location: Midwest, USA (with Travel Requirements)
EPM is working with an exceptional medical device company in the Midwest that is seeking experienced Senior Quality Engineers to join their team. This company specializes in ophthalmology, cardiovascular, and dental medical devices and is dedicated to developing high-quality, innovative healthcare solutions.
Job Summary:
We are looking for Senior Quality Engineers with expertise in sterilization processes and experience in ophthalmology, cardiovascular, or dental medical devices. This role will play a key part in ensuring compliance with global regulatory standards, leading quality initiatives, and optimizing manufacturing processes. Candidates must be comfortable with travel (60% - 70%) to suppliers, manufacturing sites, and regulatory bodies.
Key Responsibilities:
- Maintain and enhance quality systems in compliance with ISO 13485, FDA 21 CFR Part 820, MDR, and other relevant regulations.
- Lead sterilization validation efforts for processes such as EtO, Gamma, Steam, and E-Beam sterilization.
- Conduct supplier audits, internal audits, and risk assessments to ensure high product quality.
- Support CAPA investigations, root cause analysis, and process improvements.
- Collaborate with R&D, manufacturing, and regulatory teams to ensure compliance and product safety.
- Ensure adherence to GMP, GDP, and risk management (ISO 14971) practices.
- Travel up to 30-50% to suppliers, contract manufacturers, and regulatory bodies.
Qualifications & Experience:
- Bachelor's or Master's degree in Engineering, Quality Assurance, or a related field.
- 5+ years of experience in the medical device industry, preferably with ophthalmology, cardiovascular, or dental products.
- Strong expertise in sterilization validation and process control.
- In-depth knowledge of ISO 13485, FDA regulations, MDR compliance, and process validation (IQ/OQ/PQ).
- Strong analytical and problem-solving skills, with experience in CAPA and risk management.
- Ability to travel up to 30-50% domestically and internationally.
Why Join This Opportunity?
- Work with a leading Midwest-based medical device company at the forefront of innovation.
- Be part of a dynamic and collaborative team focused on patient safety and quality excellence.
- Competitive salary, benefits, and career growth opportunities.
If you're a quality-driven professional with sterilization expertise and a passion for medical device compliance, apply today!
