Quality Engineer

Orchid Orthopedics Farmington Hills , MI 48334

Posted 1 week ago

SUMMARY OF POSITION

The Quality Engineer, Sustaining Product Quality supports the ongoing quality of Orchid’s legacy products.This position reports directly to the site quality leader.

KEY JOB RESPONSIBILITIES
  • Uses quality tools to implement improvements including: process flowcharting, Pareto analysis, correlation and regression analysis, significance tests, design of experiments, statistical process control, gauge repeatability and reproducibility, and trend analysis techniques.
  • Supports continuous improvement as a change agent for internal rework and scrap reduction and process optimization.
  • Performs quality reviews and internal audits; evaluates data and writes reports to validate or indicate deviations from existing standards.
  • Conducts process and equipment validations.
  • Liaise with suppliers and customers to address concerns and resolve issues.
  • Assists in the development of essential QMS deliverables including, but not limited to:
  • complaint analysis, risk analysis, failure mode and effects analysis, CAPA, and process/equipment/software verification/validation.
  • Performs responsibilities of a Complaint Handling Unit designee including containment, root cause analysis, corrective action, review and reporting for customer returns and complaints.
  • Work with production to document current process parameters and develop written instructions to eliminate unnecessary process variation.
  • Participates in pre- and post-production reviews providing quality engineering support.
  • Supports measuring and analyzing key metrics to monitor performance.
  • Perform necessary training related to CAPA’s and continuous improvement efforts.
  • Mentors quality and production personnel on problem solving and proper inspection techniques.
  • Works with cross-functional teams to solve production and quality problems.
  • Back up the Quality Systems Specialist on Regulatory Release activities per FDA 21 CFR 820.80 (d) when required.
EXPERIENCE
  • At least 2 years of engineering experience
  • Experience in medical devices manufacturing preferred
KNOWLEDGE, SKILLS AND ABILITIES
  • Ability to apply logic and reasoning to solve complex problems, including identifying strengths/weaknesses and arriving at alternative solutions and conclusions
  • Ability to apply the fundamental quality tools (ie. Pareto charts, cause and effect diagrams, 5-Why analysis) to define, analyze, and solve problems
  • Print reading skills and thorough knowledge of Geometric Dimensioning & Tolerancing (GD&T) and the application of AMSE Y14.5M
  • Ability to multi-task to meet tight time constraints in a fast paced environment and remain well organized
  • Competent in Minitab or other software to analyze and understand data (capability studies, Gage R&R, ANOVA, etc.) and create actionable reports
  • Ability to complete customer PPAP information
  • Ability to conduct measurement correlation studies with the customer and capability studies internally
  • Ability to create final inspection criteria
EDUCATION AND CERTIFICATION
  • Bachelor's Degree in Quality Engineering, Mechanical Engineering or related technical field required
  • GD&T Certification preferred
  • CQE, CRE, CQA, CQM or other quality certification preferred.
ABOUT OUR VALUES AND LEADERSHIP COMPETENCIES

As a member of our team, leading from our values is foundational.

Values:
  • Integrity First: We Do the Right Thing
  • Teamwork: We Are All Connected
  • Relentless Pursuit: We Are Driven & Curious

If you are interested in applying for this position, please send your resume to: recruiting@orchid-ortho.com

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Quality Engineer

Orchid Orthopedics