Senior Quality Engineer, Becton Dickinson, Louisville, CO
- Leading healthcare safety and technologies for more than a century
Job Type: Full-time
Job ID: R-380200
Location: Louisville, CO
- The Sr. Quality engineer is responsible for ensuring TTM products are developed and released meeting customer expectation, regulatory requirements, appropriate voluntary standards, and BD policies and procedures.
- This position will work as a member of a TTM cross-functional project team engaged in ongoing Product Life Cycle technical support.
- Will serve as a quality representative on project core teams and will work closely with R&D, Operations, Regulatory Affairs, Marketing and Distribution.
- This position requires a self-directed individual able to handle multiple projects and tasks utilizing a high level of written and oral communication skills.
- In addition the incumbent may be expected to initiate quality initiative projects,
- become thoroughly knowledgeable with all aspects of Sustaining Engineering and/or New Product Development projects,
- and assume personal responsibility for the successful completion of all tasks within the realm of Quality Engineering responsibilities
Essential Duties and Responsibilities (Summary)
- Participates on Project Team as Quality Representative.
- Ensures that principals of Design Control are applied to Product and Process Changes and New Product Development.
- Creates, reviews and approves Quality System Documents (CAPA, Audits)
- Creates, reviews and approves Product Documents, such as Design History Files
- Creates reviews and approves Risk Management Files documents such as: Risk Management Report, Hazard Analysis, Risk Benefit Analysis and FMEA’s
- Provides supervision to technicians and engineers
- Performs Internal or Supplier Quality System Audits.
- Ensures compliance to Department and Division procedures.
- Drives Reliability planning and Quality Planning for New Product Development.
- Interfaces with manufacturing facility or other Division Facilities.
- Extensive knowledge of medical device regulation, industry or international standard, including management responsibility.
- Ability to interface with regulatory bodies to present technical information
- Comprehensive knowledge of quality systems and relationship to business.
- Understands basic applied statistics, statistical sampling plans, and statistical process control and advanced statistical methodologies such as DOE and Taguchi.
- Broad knowledge of manufacturing processes.
- Understands Fundamentals of Engineering Principles.
Education and/or Experience
- B.S. in Engineering, Engineering Technology, Science or related field a minimum.
- Minimum 7 years of experience with FDA regulated industry including 3 years on product development programs.
- 1 - 2 years experience with electromechanical devices
- American Society of Quality (ASQ) certification (CQE, CQA, CQM, etc.), preferred