Quality Engineer

MicroPort • Arlington, TN

2d

About The Position

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

Requirements

• 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
• Quality Engineer I Required: Associate’s Degree or equivalent post-secondary education in a technical field, Engineering preferred
• Quality Engineer II Required: Bachelor’s Degree in technical field, Engineering preferred
• Quality Engineer I Associate’s Degree: 3 years’ related experience in medical devices or related field
• Quality Engineer II 3 years' related experience required in medical devices or related field

Nice To Haves

• American Society for Quality (ASQ) certification as a CQA or CQE is preferred
• Quality Engineer I Preferred: Bachelor’s Degree in technical field, Engineering preferred
• Quality Engineer II Preferred: Master’s Degree in technical field, Engineering preferred
• Quality Engineer I Bachelor’s Degree: no related experience required

Responsibilities

• 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
• Train new engineers and technicians in basic or advanced Quality tools and techniques
• Lead process and design risk analysis and validation teams
• Lead Material Review Boards and look for opportunities to reduce/eliminate scrap

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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree
• Number of Employees: 1,001-5,000 employees