Quality Engineer I
About The Position
We’re a company of agile, customer‑oriented individuals with a shared commitment to integrity, servant leadership, and teamwork. Our associates take pride and ownership in their work and innovate to provide the highest‑quality, life‑enhancing medical technology in the world. Together, We’re in It for Life. The primary purpose of this role is to support Operations in ensuring that Quality System requirements are consistently met for medical device manufacturing and related activities, in accordance with applicable regulatory and standards requirements. What you will do: Ensure compliance with QMS, EMS, , and company procedures Support audits, inspections, and investigations Review manufacturing processes and DHRs for accuracy and compliance Assist with risk analysis, validations, and process improvements Help develop inspection methods and quality procedures Support nonconforming material review and corrective actions Conduct complaint investigations and contribute to CAPA activities Assist with product transfers and cross‑functional quality support
Requirements
- Ability to read and write in English.
- Experience with Microsoft tools.
- Self‑motivated with strong adaptability to change.
- BS degree in a related discipline or High School Diploma with 5+ years of relevant experience.
Nice To Haves
- Degree in Engineering or related field (preferred)
- Early‑career experience in quality or manufacturing
- Strong communication and problem‑solving skills
- Interest in working in a regulated environment
- Knowledge of statistical tools (preferred).
Responsibilities
- Ensure compliance with QMS, EMS, , and company procedures
- Support audits, inspections, and investigations
- Review manufacturing processes and DHRs for accuracy and compliance
- Assist with risk analysis, validations, and process improvements
- Help develop inspection methods and quality procedures
- Support nonconforming material review and corrective actions
- Conduct complaint investigations and contribute to CAPA activities
- Assist with product transfers and cross‑functional quality support
Benefits
- Medical, dental, and vision benefits-effective date of hire!
- Company-paid life insurance and disability benefits
- Generous Paid time off and 10 paid Holidays
- 401k Plan with Company Match
- Tuition Reimbursement
- Voluntary Universal Life and Long-Term Care
- Voluntary Legal Plan
- Pet Insurance
- Home Ownership Program
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
