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Senior Quality Engineer




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

Provide product quality, supplier quality, design assurance, and quality-by-design input and expertise to the development of new medical devices, as well as changes to existing commercialized devices. Provide direction in product risk management throughout entire product lifecycle and assure compliance to ACIST design control procedures, applicable regulations and external standards. Works collaboratively with Product Quality Team to deliver results that improves the overall product platform. Identify areas of improvement, and either lead the necessary activities to completion or participate as an active member providing guidance to the team.

 

Provide hands-on technical quality engineering support for new product transitions internally and externally into commercialized production including development of quality requirements/plans for new products, design/process validation requirements, test method validation and ongoing change management for finished device manufacturing.  The role works upstream and downstream ensuring the total product lifecycle is maintained and that our products continue to perform as designed.

 

Product Quality Engineering

  • Provide quality support for manufacturing, inspection & test activities for products supported.
  • Lead product complaint investigation, analysis, and final report creation
  • Conduct statistical analysis of product use data (complaints) and non conformance data for the identification of trends and suggests/coordinates the implementation of necessary corrective actions.
  • Provide Quality Assurance support for CAPA activities relating to products and process, and leading other efforts relating to quality characteristics and conformance to product requirements.
  • Review and approve change orders related to product/process changes. Changes include approval of procedures and work instructions for design, manufacturing and inspection.
  • Participate in internal audits as needed.
  • Participates in the Material Review Board (MRB), reviewing and approving material disposition and identifying any required changes to the quality system or quality plan.
  • Interact with engineering team to support product development and ongoing sustaining activities.
  • Establish robust manufacturing process metrics and monitor results regularly to proactively identify potential problems and drive continuous improvement.
  • Provide leadership and QA support for validation of production and test processes.

Design Assurance

  • Provide direction and technical expertise to product development teams regarding quality characteristics and conformance to product requirements associated to software, electrical, mechanical, and consumable products.
  • Drive the Design Control process and own the Design History File (DHF) within the framework of regulatory requirements.
  • Ensure that specifications and requirements are relevant, capable, contain essential elements and meet applicable standards, and that all requirements are suitably testable and verified.
  • Provide guidance and support for design verification activities. Assess protocols and reports test robustness, traceability to requirements, and statistical sample sizes, and quality of the test spec.
  • Lead all risk management activities from planning, analysis and verification, and risk reporting and acceptance.
  • Provide engineering expertise and support for external testing qualification, technical standards interpretation, and appropriate statistical methods, including sample size determination.
  • Generate the QA deliverables to meet the project scope and plan.
  • Review, provide input and approve project-related deliverables and change orders.
  • Work with external design/test organizations to ensure Design Control requirements are fulfilled and appropriate supplier controls are in place.
  • Work with Engineering to develop production acceptance criteria, test methods, and process validation protocols.
  • Review Design History Files and Technical Files for conformance to applicable requirements.
  • Prepare technical sections of regulatory approval applications by identifying the testing needed to support global submission, and identifying U.S. and non U.S. product and safety standards.

 

Supplier Quality:

  • Participate in and lead supplier evaluation, qualification and approval activities including audits.
  • Provide quality support for incoming inspection plans, procedures, and sampling methods to ensure product quality.
  • Assist in defining critical attributes and characteristics to be measured for components and products.
  • Define component qualification plans and approve first part review results.
  • Own and complete Supplier Corrective Action Requests (SCAR), interfacing directly with suppliers.
  • Oversee supplier validations, change orders, and any changes to form, fit, or function of the device.
  • Provide direction and oversight to contract manufacturer for quality concerns, product inquiries, validations, safety, etc.

 

Leadership and Supervision

  • Provide coaching and guidance to staff. Provide consultation on complex projects.
  • Promote employee development and foster growth of employees through:
  • Oversee and/or conduct training of new and existing employees and facilitate assimilation of new members and changes
  • Identify resource needs (human, equipment, etc.) and communicate to management for improvement as needed, addition of capabilities, and future growth projections to support a growing business.
  • Performance Management
  • Skills development
  • Continuous one-on-one feedback
  • Bi-annual appraisal of individual performance
  • Recognition and motivational techniques/tools to drive high levels of employee performance and engagement

 


Qualifications (Knowledge, Skills & Abilities):

Minimum:

  • BS in Engineering or related experience with a comparable science degree.
  • 5+ years engineering experience
  • 3-5 years of experience in the Quality Engineering/Design Assurance capacity in the medical device industry
  • Strong working knowledge of the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive
  • Demonstrated knowledge and proficiency in the application of ISO 14971 and other standards related to product design and medical devices
  • Experience managing design assurance/quality engineering deliverables for medical device systems (e.g. medical devices that utilize electro-mechanical components, software, and associated consumable devices)
  • Demonstrated knowledge and proficiency in quality principles and best practices
  • Moderate level of computer proficiency including MS Word, Excel, and statistical applications software
  • Effective oral and written communication skills
  • Effective technical writing skills
  • Strong leadership skills with the ability to influence without direct authority
  • Ability to work effectively with suppliers and contract manufacturers
  • Ability to lead supplier audits and overall qualifications and maintenance
  • Demonstrated knowledge and proficiency in problem solving, root-cause analysis, and corrective and preventative actions
  • Demonstrated knowledge and proficiency in statistics, data analysis and trending, and reporting of results.

 

Preferred:

  • ASQ CQE (Certified Quality Engineer) or 6 Sigma discipline
  • Demonstrated knowledge of pre-market submission in U.S and Europe
  • Skilled in the application of statistical methods, including ANOVA, statistical process control, sampling plans, gauge R&R, and design of experiments
  • Skills in other technical areas such as verification testing, sterilization validation, and software quality

 

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 minimal. Travel to facilities would be about 1-3 days duration each trip with total travel expected to be less than 10%.

Job Location

Eden Prairie, MN

Tracking Code

718-432

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