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Senior Supplier 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

Position Summary:
The Senior Supplier Quality will provide supplier quality input and support for products manufactured by ACIST Medical Systems. This role collaborates with the Supplier Quality Team to deliver results that improves products and identifies areas of improvement. This role also provides direction in product risk management throughout the entire 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 is maintained and that our products continue to perform as designed.

Primary Duties and Responsibilities:

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 manufacturers for quality concerns, product inquiries, validations, safety, etc.
• Identify, Develop, and Implement systems that foster collaboration and communication with suppliers.
• Establish robust measures for supplier quality performance, monitor results regularly, and initiate appropriate actions to continually improve supplier quality performance.
• Participate in and lead continuous improvement projects.
• Manage Supplier scorecards and monitor overall health of Supplier.
• Manage the material review board for Operations including data generation and analysis, meeting execution, any follow up activities, meeting minutes, and filing of all MRB records.

Receiving Inspection and Manufacturing Quality Assurance:
• Resolve NCMRs related to incoming material inspections.
• Assist in defining critical attributes and characteristics to be measured for components and products.

Leadership and Supervision
• Provide coaching and guidance to staff.
• Promote employee development and foster growth of employees through:
o Performance Management
o Skills development
o Continuous one-on-one feedback
o Bi-annual appraisal of individual performance
o Recognition and motivational techniques/tools to drive high levels of employee performance and engagement
• 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.

 


Qualifications (Knowledge, Skills & Abilities):

Minimum:

• B.S in Electrical, Mechanical, or Software Engineering or related experience with another engineering or science degree.
• 5 years engineering experience
• 3-5 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, ISO 13485, and the Medical Device Directive
• Experience supporting design assurance/quality engineering deliverables for medical device systems
• 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
• Moderate level of computer proficiency including MS Word, Excel, ERP systems, and statistical applications software


Preferred:

• ASQ CQE (Certified Quality Engineer) or 6 Sigma discipline
• ASQ CQA (Certified Quality Auditor) or related auditing certification
• Knowledge and experience with IEC standards such as 60601-1, 60601-1-2, and other related standards for the product type
• Ability to coordinate multiple projects simultaneously
• 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 3-5 days duration each trip with total travel expected to be approximately 15%.


Job Location

Eden Prairie, MN

Tracking Code

738-432

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