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Product Quality Engineer II




Why Join ACIST?

We care as much about our employees as we do our patients. Our culture fosters a work environment where employees can thrive, be passionate and have fun along the way.  Each member of the ACIST team has the power to make a difference......every day!


Position Description

Position Summary:  

 

Provide product quality, design assurance, and supplier quality input and support to new and commercially available products. This role collaborates with others in the organization to deliver results that improve the overall product performance. Identify areas of improvement and lead the necessary activities to completion, or participate as an active member providing guidance to the team.  Provide support to product risk management throughout the entire product lifecycle and assure compliance to ACIST design control procedures, applicable regulations and external standards. The role works upstream and downstream ensuring the total product lifecycle for ACIST products is maintained and that they continue to perform as designed.

 

Primary Duties and Responsibilities:

Product Quality Engineering

  • Provide quality oversight and support to manufacturing, design assurance, and suppliers.
  • Develop and maintain plans for sustaining projects to ensure compliance with established policies, regulations, and customer & design requirements.
  • Lead the investigation, analysis, and report on product complaints and coordinate cross-functional actions as needed.
  • Provide leadership and QA support for NCMR and CAPA activities relating to products and processes.
  • Review and approve change orders related to product/process changes, including approval of procedures and work instructions for manufacturing and inspection.
  • Provide leadership and QA support for validation of production and test processes.
  • Provide direction and oversight to contract manufacturer for quality concerns, product inquiries, validations, safety, etc.
  • Evaluate corrective actions for effectiveness to assure conformity to quality specifications.
  • Establish robust manufacturing process metrics and monitor results regularly to proactively identify potential problems and drive continuous improvement.

 

Supplier Quality

  • Participate in component supplier selection, evaluation and approval activities, including supplier audits.
  • Engage component suppliers to qualify new components and resolve quality concerns.
  • Assist in defining critical attributes and characteristics to be measured for components and products.
  • Approve first part review and component qualification results.
  • Manage supplier corrective action requests and interface directly with suppliers.

 

 Design Assurance

  • Provides direction and support to product development teams.
    • Lead product risk management activities from planning, analysis, verification, and reporting.
    • Provide engineering expertise and support for product testing and verification activities.
    • Work with Engineering to develop production acceptance criteria, test methods, and validation protocols.
    • Support new product development for respective product line and lead/participate in gate reviews and follow up activities ensuring all documentation and data supports the approval process.
    • Lead risk analysis and risk management for assigned product through all phases of the product life cycle and author the annual post market surveillance and drive resolution of identified risks.
  • Provide engineering support for external testing qualification such as UL / IEC testing, and appropriate statistical methods, including sample size determination

Qualifications (Knowledge, Skills & Abilities):

 Minimum: 

  • BS degree in Engineering or comparable science discipline.
  • 3-5 years engineering experience
  • 2+ years of experience in the Quality Engineering, Supplier Quality, and/or Design Assurance capacity in the medical device industry
  • Working knowledge of process validation, test method validation, and R&R study
  • Demonstrated knowledge and effective application of quality tools (e.g., Six Sigma, DOE, process analysis/capability, FMEA, root cause analysis, statistical data analysis, CAPA)
  • Working knowledge of the FDA Quality System Regulation and ISO 13485
  • Experience supporting design assurance/quality engineering deliverables for medical device systems
  • Ability to influence without direct authority
  • Ability to establish effective relationships with suppliers
  • Moderate level of computer proficiency including MS Word, Excel, ERP systems, and statistical applications software
  • Strong written and verbal communication skills to effectively translate ideas, concepts and information
  • Ability to develop clear, concise, and timely oral and written reports

  

Preferred:

  • ASQ CQE (Certified Quality Engineer) or 6 Sigma discipline

 

Other: 

  • Mental demands – work is detail oriented, often with multiple priorities. The environment is deadline sensitive and may be exposed to high-pressure situations. 
  • Travel requirements are moderate. Travel to facilities would be about 2 – 3 days duration each trip with total travel expected to be approximately 10-15%.

 

ACIST provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.


Job Location

7905 Fuller Road, Eden Prairie, MN

Tracking Code

743-432

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