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Job Title Lead Quality Engineer
Job Description If you are a Colorado resident and this role is a field-based or remote role, you may be eligible to receive additional information about the compensation and benefits for this role, which we will provide upon request. You may contact 888-367-7223, option 5, for assistance.In this role, you have the opportunity toThe Lead Quality Engineer provides support to ensure the organization is in compliance with the legal, regulatory and standards requirements for the quality system (ISO 9001, moving to 13485) and applicable procedures in the area of Operations in Latham factory as well its local and global interfaces. They will also ensure product compliance according applicable standards and requirements prior to distribution to Philips system manufacturing facilities. The lead quality engineer drives continuous product quality and process improvement.You are responsible for:- Acting as a lead and mentor for the Ops QA Device History File (DHR) and Calibration team. This will involve coaching of behaviors and teaching of quality tools and concepts.
- Helping to field escalations by providing clarity and focus.
- Complete special quality initiatives and projects to ensure improvement in Quality metrics such as but not limited to; Out of Tolerance Investigation, First Pass Yield, CONQ, Defect Rate, Customer Complaints, Process Validation Completion.
- Provides effective oversight of the execution of the Quality Plan, support any Risk Management activities, and all design related activities during the product/system lifecycle
- Performs independent technical assessment of product quality performance and post-market product quality analysis. Use this assessment to ensure teams are focused on the largest return / improvement opportunities.
- Lead improvement in the Calibration System, and support Calibration Procedures, Records, and Audits.
- Uses post-market analytics and statistics to report on product quality performance in the field (provide feedback to manufacturing, suppliers or design teams).
- Responsible for performing timely, detailed quality engineering tasks like:
- Assessing product designs
- Reviewing test and other performance data
- Analyses of market complaints
- Completing or assisting with root cause analysis and quality problem solving.
- Individual contributor interacting frequently with Sr. management and peer groups. Possible growth to direct supervision of DHR and Calibration teams.
- Works on issues where analysis of situation or data requires review of relevant factors. Exercises judgment within defined procedures and policies to determine appropriate action.
- 5+ years of Quality Engineering experience in a regulated environment, preferably within Medical Device.
- 3+ years of experience with Calibration / Calibration Systems
- Bachelor's degree in a scientific discipline, Engineering preferred. (Associates degree with added experience acceptable)
- Strong GD&T background required.
- Self-starter motivated with continuous improvement mindset/culture
- Independently produces and completes Quality Engineering Documents. Can develop & administers quality related project plans and schedules.
- Responsible for performing timely, quality engineering tasks like:
- •Assessing quality plans and product designs
- •Reviewing test and other performance data
- •Analyses of market feedback
- •Leading root cause analysis and quality problem solving.
- Works on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends. Follows processes and operational policies in selecting methods and techniques for obtaining solutions.
- ID: #21587105
- State: New York Latham 12110 Latham USA
- City: Latham
- Salary: USD TBD TBD
- Job type: Permanent
- Showed: 2021-10-23
- Deadline: 2021-12-20
- Category: Architect/engineer/CAD