What are the responsibilities and job description for the Quality Engineer position at MicroPort Job Board?
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At MicroPort, we relentlessly strive to master every detail of our medical solutions with the purpose of prolonging and reshaping the lives of patients everywhere. We welcome motivated and talented people who want to join our dynamic and inclusive company, working together to deliver meaningful medical breakthroughs. In order to accomplish this, we hold true to our core values of Quality, Integrity, Accountability, Efficiency, Innovation, Aspiration, Dedication & Collaboration. Come and join Team MicroPort!
Why You’ll Love MicroPort
You will find our team atmosphere challenging and rewarding. In addition to working with a world-class team, receiving a competitive base salary and bonus opportunities, our U.S. employees also enjoy the following benefits: Medical, Dental, Vision, Maternity Leave, Life Insurance, Short-Term Disability, Long-Term Disability, Bereavement, 401(k) (up to 4% match with vesting from day 1), PTO, Paid Holidays, Employee Assistance Program, Education Assistance...and more! At MicroPort, we care about our employees and encourage them to make healthy lifestyle choices and embrace wellness opportunities to maintain their very best health and wellbeing.
Overall Summary
As Quality Engineer, you will support all areas of MicroPort (MPO) Research & Development, Regulatory Affairs, Operations and Quality with knowledge in quality systems, medical device regulations, and continuous improvement while assuring compliance with MPO’s Quality System and regulatory requirements.
You will be the primary contact for Process and Product Development Teams (PDT) on topics of quality systems and process improvement.
Your duties will include:
Quality Engineer I:
- Participate on process and design risk analysis and validation teams
- Devise and implement methods and procedures for inspecting, testing, and evaluating product conformance (including specialized gauging and inspection instructions)
- Participate in Material Review Boards and look for opportunities to reduce/eliminate scrap
- Support risk management activities, such as failure/complaint investigations, risk assessments and CAPA teams
- Participate on Product Development Teams (PDT) and provide feedback on product design (through DFM and DFQ) and design transfer activities
- Provide technical Quality support to inspection and manufacturing
- Support the Quality Audit Program
- Monitor and analyze process performance in manufacturing and use nonconforming product data to identify products or processes requiring improvements
Quality Engineer II:
- Train new engineers and technicians in basic or advanced Quality tools and techniques
- Lead process and design risk analysis and validation teams
- Devise and implement methods and procedures for inspecting, testing, and evaluating product conformance (including specialized gauging and inspection instructions)
- Lead Material Review Boards and look for opportunities to reduce/eliminate scrap
- Support risk management activities, such as failure/complaint investigations, risk assessments and CAPA teams
- Participate on Product Development Teams (PDT) and provide feedback on product design (through DFM and DFQ) and design transfer activities
- Provide technical Quality support to inspection and manufacturing
- Support the Quality Audit Program
- Monitor and analyze process performance in manufacturing and use nonconforming product data to identify products or processes requiring improvements
Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
About You
We might be a great match if you have:
Working knowledge of:
o Medical device regulations (FDA, ISO, MDR etc.)
o Design controls
o Risk management including FMEA (Failure Modes and Effects Analysis)
o Process validation/verification activities
o Root cause analysis
o Statistical techniques and methods
o Geometric Dimensioning and Tolerancing (GD&T)
o Measurement system evaluation including Gage R&R
o Basic and advanced metrology tools and systems
o Fundamental industrial engineering (product routings and BOMs)
o Microsoft office products (Word, Excel, Access, PowerPoint, and Project)
o CAD software (NX, Solidworks or AutoCAD)
Ability to:
o Communicate (verbal and written) in a clear and concise manner
o Lead, participate and contribute on teams to complete cross-functional projects
o Work independently, analyze complex problems, and apply practical solutions
o Prioritize multiple projects and assignments consisting of varying degrees of complexity
Licensure, Registration and/or Certification
American Society for Quality (ASQ) certification as a CQA or CQE is preferred
YOUR EDUCATION
Quality Engineer I
Required: Associate’s Degree or equivalent post-secondary education in a technical field, Engineering preferred
Preferred: Bachelor’s Degree in technical field, Engineering preferred
Quality Engineer II
Required: Bachelor’s Degree in technical field, Engineering preferred
Preferred: Master’s Degree in technical field, Engineering preferred
YOUR EXPERIENCE
Quality Engineer I
Associate’s Degree: 3 years’ related experience in medical devices or related field
Bachelor’s Degree: no related experience required
Quality Engineer II
3 years' related experience required in medical devices or related field