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Senior Quality Engineer

  • Permanent
  • Anywhere

Website Tactile Medical

Tactile Medical

Company : Tactile Medical

Country: United States

Location : Saint Paul, Minnesota

Post: Sat, 30 Jul 2022 21:02:00 GMT

Expires: Sat, 27 Aug 2022 23:59:59 GMT

Apply Job : Apply Online

—————————— Job Description ——————————

Overview:
The Senior Quality Engineer is responsible for maintaining and improving the quality of Tactile Medical products and processes and improving supplier management and performance.

Responsibilities:
Supplier Quality

Evaluate and communicate quality issues to suppliers and applies sound, systematic problem-solving methodologies in identifying, prioritizing, and resolving quality issues

Review and approve supplier corrective action plans and verification of effectiveness documentation

Monitor supplier performance and supports efforts to develop and implement changes to improve the production process. Coordinate the evaluation of proposed changes at suppliers

Plan and lead audits of suppliers to assess compliance with regulatory and Tactile Medical requirements, including audit scheduling investigation, and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions

Collaborate with Manufacturing, Supply Chain, and Engineering as needed to address supplier quality issues

Design Assurance

Lead the development of and coordinate the execution and documentation of Design Validation and Verification activities

Partner with R&D to determine and implement Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.

Plan and conduct analysis, inspection, design, testing and/or integration of test methods to assure the quality of assigned products or components

Coordinate the documentation review, inspection workflow, training, problem solving and calibration for Tactile Medical products and test equipment

Develop test methods and participate in the assessment of incoming, in-process and final test/inspection

Perform root cause investigations and develop corrective action plans for product and process non-conformities

Perform standard quality engineering reviews of design documentation for compliance with stated requirements, including supplier quality and company quality records

Utilize statistical analysis techniques to determine product acceptance and AQL sampling plans, evaluate process capabilities and develop statistically sound tolerance limits

Post Market

Robust understanding of inspection processes using standard metrology techniques

Define and manage the receiving process to ensure quality conformance

Develop and implement, receiving inspection instructions on required product

Perform quality related functions on product associated with customer complaints

Participate in the non-conformance reporting system, driving timely disposition and closure. Lead and/or participate in MRB meetings. Identify non-conformance trends and develop and administer technical investigation and corrective action plans to resolve recurring quality problems

Other

Coordinate the tasks for the electronic Quality Management System (QMS)

Considered a high-level specialist who regularly interacts and works with senior management. Uses advanced techniques, theories, and processes to complete work

Develop, monitor, coach and supervise staff, ensuring the development of employees through orientation, various training, and feedback

Advise on changes and their implementation and provides training, tools, and techniques to enable others to achieve quality

Assist in ensuring quality during all phases of production

Serves as liaison to design, procurement, and manufacturing engineering

Other duties as assigned

Qualifications:
Education & Experience

Required:

­­­BS in Engineering or related technical discipline

6+ years of experience as a Quality Engineer within the medical device industry

Previous experience with CAPA

Ability to travel up to 15%

Preferred:

Certified Quality Engineer (CQE) and/or Certified Quality Auditor (CQA)

Knowledge & Skills

Medical Device Quality System Knowledge Including 21 CFR Part 820 (QSR) & ISO 13485

Demonstrated skills in statistical analysis

Exceptional computer skills

Ability to work in a fast paced, dynamic and growth environment

Excellent interpersonal skills: ability to articulate verbally and written, review, analyze, summarize, and interpret data; draw conclusions and make appropriate recommendations and decisions; write reports; and lead or conduct teams and meetings

Proven ability to work with minimal direction, as well as be resourceful and independent in solving problems and multi-task effectively

Ability to supervise a team, providing assessment, training, feedback, and guidance

Competencies:
Planning

Communication

Priority Setting

Peer Relationships

Problem Solving

Conflict Management

Functional/Technical Skills

Change Agent

Process Management

Analytical

Detail Oriented

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