Farmington Hills , MI 48334
Posted 1 week ago
This Job is not relevant Tell us why
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.
- 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: firstname.lastname@example.org