Job Description Summary

Job Description

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

• Represents the Corporation, Division and Quality Department in a professional manner.

• Participates on Project Team as Quality Representative.  Ensures that principals of Design Control are applied to Product and Process Changes and New Product Development.

• Provides Quality Assurance leadership for Project Teams or Quality Department.

• Creates, reviews and approves Quality System Documents (CAPA, Audits)

• Creates, reviews and approves Product Documents, such as Design History Files

• Creates, reviews, and approves Protocols, Process and Product Validations, Stability Protocols, Software Validation documents and Test Method Validations

• 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

• Analyzes process and product non-conformance and implement comprehensive corrective and preventive action plans.

• Performs Internal or Supplier Quality System Audits.

• Ensures compliance to Department and Division procedures.

• Participates and has membership in trade and/or professional organizations to ensure that state-of-the-art industry standards are communicated into the division in an efficient, timely, and accurate manner.

• Drives Reliability planning and Quality Planning for New Product Development.

• Perform failure investigations and implement comprehensive corrective and preventive action plans using methodologies as Six Sigma/Lean Six Sigma

• Interfaces with manufacturing facility or other Division Facilities.

• Other duties as assigned.

QUALIFICATIONS

• Ability to perform engineering work of a broad nature with little or no direction from Quality Management.  Generally, receives guidance on novel or controversial problems.

• Extensive knowledge of medical device regulation, industry or international standard, including management responsibility.  Ability to understand Division and Plant Quality Systems and be able to implement systemic changes to enhance product quality and improve business efficiency.  Ability to interface with regulatory bodies to present technical information.

• Comprehensive knowledge of quality systems and relationship to business.

• Has experience in writing process, software, and equipment protocols/validations and has fundamental knowledge of validation principles.

• Understands basic applied statistics, statistical sampling plans, and statistical process control and advanced statistical methodologies such as DOE and Taguchi.

• Ability to participate and provide leadership on teams and maintain positive work environment with those teams.  Understands team functions, leadership techniques and project management methodologies. 

• Broad knowledge of manufacturing processes. 

• Excellent communication skills (verbal, written, and presentation).  Understands how to present information dependent upon the level of the audience.

• Understands Fundamentals of Engineering Principles.

• Ability to effectively manage time and handle multiple task assignments.

• Ability to translate quality requirements into product specifications and interpret Regulations, Corporate, Division and Department Procedures.

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

At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture.  We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under “Our Commitment to You”. The anticipated compensation range for this position is $81,300.00 - $134,100.00 USD Annualand the compensation offered will depend on the candidate’s qualifications.

*BD follows the Pay Transparency and non-discrimination provisions described by the Colorado Department of Labor and Employment (CDLE).

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

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