Quality Engineer II - Medical Device Manufacturing
Location: Miami, Florida
Working Situation: Onsite
Join a world leader in medical device innovation, transforming surgical care and improving patients' lives globally. The commitment to cutting-edge research and compassionate healthcare solutions ensures that every day brings new challenges and opportunities for growth. Be part of a team where your expertise and passion will drive impactful advancements in medical technology.
We are seeking a Quality Engineer II to join our esteemed global medical device company, celebrated for its groundbreaking advancements in product development. As a pivotal member of our team, you will ensure our products meet the highest quality standards and regulatory requirements. You will have the opportunity to work cross functionally and collaboratively with keys stakeholders at the site. If you have a passion for excellence and a drive to make impactful contributions in the industry, we want to hear from you!
The Quality Engineer II will be responsible for:
- Analyze design drawings for tolerance, inspectability, and quality issues.
- Collaborate with suppliers to enhance quality and assist in process validations.
- Train QC Inspectors on inspection techniques and new equipment usage.
- Participate in internal and external quality audits.
- Lead or assist in PFMEAs and Risk Assessments.
- Perform tasks in the Engineering Change Management process.
- Oversee or support First Article Inspections and review reports.
- Lead or assist in equipment and process validations (IQ, OQ, PQ).
- Develop inspection methods and gauges with Metrology.
- Create and review inspection method work instructions.
- Conduct Measurement System Analysis (Gage R&R) studies.
- Develop inspection plans for receiving and in-process inspections.
- Investigate complaints and manage Nonconformances (NCRs).
- Conduct trend analysis and lead quality review meetings.
- Lead or support Continuous Improvement projects.
- Lead or support Environmental Monitoring programs.
- Perform Root Cause Analysis and define Corrective/Preventive Action Plans (CAPAs).
The Quality Engineer II will have the following qualifications:
- Bachelor's degree in Engineering or Engineering Technology required.
- Minimum of 2 years' experience in Quality Control or Quality Assurance position in a Medical Device Company required.
If you are interested in the Quality Engineer II position, apply now!
