Quality Engineer

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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 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 Youll Love MicroPort

You will find our team atmosphere challenging and 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 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 MPOs 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:Associates Degree or equivalent post-secondary education in a technical field Engineering preferred

Preferred:Bachelors Degree in technical field Engineering preferred

Quality Engineer II

Required:Bachelors Degree in technical field Engineering preferred

Preferred:Masters Degree in technical field Engineering preferred

YOUR EXPERIENCE

Quality Engineer I

Associates Degree:3 years related experience in medical devices or related field

Bachelors Degree: no related experience required

Quality Engineer II

3 years related experience required in medical devices or related field

Required Experience:

IC