Quality Engineer I
The Quality Engineer I is an entry-level role responsible for ensuring product quality and compliance with established standards through audits, inspections, and testing within the orthopedic medical device industry. This position involves cross-functional collaboration with internal teams and suppliers to implement quality goals, develop corrective actions, and support product and process specifications. The role requires foundational knowledge of quality systems, measurement tools, and regulatory standards, with opportunities for professional growth.
About Careertakes
👉 Important disclosure: Careertakes is a third-party recruiting platform supporting this hiring process. If selected, you will be employed directly by our client, Engineering.
Applicants for this role may also receive access to additional matched opportunities through the Careertakes platform.
What You’ll Do
The Quality Engineer I is an entry-level role responsible for helping ensure products meet defined quality, regulatory, and customer requirements through inspection, testing, audits, and support for corrective actions. You will work closely with cross-functional teams and suppliers to implement the confidential client's quality objectives.
- Formulate and document procedures, specifications, and standards for products and processes.
- Support development and implementation of corrective and preventative action (CAPA) plans.
- Collect, analyze, and report gauge and product evaluation data.
- Identify critical personnel, gauges, procedures, and materials required for new product introductions.
- Support supplier quality activities to ensure suppliers have the information and facilities needed to deliver conforming product.
- Perform basic inspections and testing; use metrology equipment (optical comparators, CMMs) under supervision.
What We’re Looking For
- Strong teamwork and relationship-building skills across internal teams and external suppliers.
- Results-oriented with the ability to meet deadlines and follow through on action items.
- Clear written and verbal communication across multiple organizational levels.
- Proficiency with Microsoft Office (Excel, Word, PowerPoint).
- Basic blueprint reading and knowledge of geometric dimensioning & tolerancing (GD&T).
- Understanding of QSR / ISO regulations and medical device quality practices.
- Familiarity with design assurance, FMEA, and product testing methodologies.
- Experience or comfort using optical comparators and coordinate measuring machines (CMMs).
Education & Experience
- B.S. in Engineering or a related bachelor's degree. Alternative bachelor’s degrees with relevant quality certification are also acceptable.
- Certification as a Quality Engineer (e.g., CQE) preferred but not required.
- Medical device experience preferred; orthopedic industry experience a plus.
- Demonstrated potential and willingness to learn in a regulated manufacturing environment.
Details & Compensation
- Employment type: FULL_TIME (temporary assignment)
- Duration: 12 months
- Work type: Onsite — Winona Lake, IN
- Pay rate: $41.10 / hour
- Authorization: Candidates must be legally authorized to work in the U.S.
- Note: Employment is with the confidential client; offers may be contingent on background checks and other pre-employment screenings as allowed by law.
Equal Opportunity & Hiring Transparency
Careertakes and our client are Equal Opportunity Employers committed to building a diverse and inclusive workforce. We prohibit discrimination or harassment of any kind. To support a fair and efficient hiring process, AI tools may be used to assist with application review or resume screening. These tools do not replace human decision-making. Final hiring decisions are made by people.
If you have questions about how your data is used, please contact us directly.
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