Senior Quality Engineer
Ann Arbor, MI
This position is a key technical role responsible for the development, implementation, improvement and continuous reinforcement of established Quality Assurance fundamental practices. The role involves hands-on work with MC3 and our suppliers in the areas of design, design transfer, test method validation, manufacturing, distribution, and/or service.
- Ensures quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility.
- Supports continuous product and process improvement through detailed failure analysis for non-conformances, and investigates, develops and implements effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions (CAPA Program). Able to lead, develop, communicate & implement essential containment or corrective actions effectively under potentially stressful situations.
- Utilizes risk management tools and aids for use by the organization in accordance with documented procedures, including but not limited to PFMEA, DFMEA, Fault Tree Analysis, Failure Mode Analysis, etc. Supports design mitigation and process mitigation plans and strategies that are designed to mitigate the risks identified through the Risk Management process.
- Conducts and provides direction for tests and ensures test compliance to test requirements through development, validation, and execution of tests for various other types of products and equipment
- Implement and deploy test fixtures, testing apparatus and machines and verify and validate their performance
- Develops Master Validation Plans and Control Plans and executes to these plans.
- Validate test methods
- Develops process improvement plans using a variety of Quality and Continuous Process Improvement tools, including but not limited to Reliability Engineering Analysis, Software Verification and Validation, Accelerated Stress Testing principals, Six Sigma, Lean Manufacturing, 5S, Statistics, engineering studies, Gauge R&R, etc.
- Establish suppliers, ensure supplier requirements and validation activities are properly completed
- Perform external audits and participate in internal audits
- Perform a broad variety of tasks in support of product and process design as assigned by the departmental manager for mission critical needs.
- Manages the Incoming Quality Assurance team.
Qualifications for the successful candidate include:
- Bachelors of Science Degree in Engineering
- 4 years’ experience, at least one year in life science regulated industry, experience in manufacturing of sterile medical products a plus.
- Exceptional analytical, problem solving & root-cause analysis skills.
- Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), medical device quality system experience & demonstrated experience interfacing with regulatory bodies and FDA.
- Excellent communication skills (written and oral). Team player with demonstrated collaboration, negotiation & conflict resolution skills.
- Ability to multi-task & handle talks with competing priorities effectively.
- Demonstrated understanding of test method validations
- Demonstrated understanding of statistics & experience with continuous quality / process improvement tools: (As defined by the local site, e.g. SPC, Lean, Six Sigma, 5S)
- Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and database applications.
Download the PDF file for position responsibilities and qualifications
MC3 offers a full and comprehensive benefits package including medical, dental and a generous paid time off policy.
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