Job DescriptionJob Summary:The Manager, Quality Engineering supports the development and implementation of the Quality Management strategy for the WWISD Design Center in collaboration with ISD Quality Leadership. The role provides quality engineering leadership, oversight, and direction, sustains a compliant QMS, and supports new product development and product maintenance through application of quality engineering principles for medical devices.
Job Responsibilities: (Primary Duties, Roles, and/or Authorities)
- Lead development, sustenance and continuous improvement of quality systems compliant with 21 CFR 820 and ISO 13485.
- Execute, measure and report progress of Quality strategic initiatives.
- Ensure policies, procedures and systems produce products meeting quality and regulatory requirements.
- Provide Quality Engineering support and promote statistical tools in design and development activities.
- Lead Risk Management activities in compliance with ISO 14971.
- Support continuous improvement of quality and market competitiveness.
- Develop department skills and resources to maintain quality assurance effectiveness.
- Develop technical solutions to complex quality problems.
- Lead a team of Quality Engineers at the design center.
- Perform functional activities with minimal direction.
- Provide leadership for multidisciplinary projects.
- Serve as a site and functional Subject Matter Expert for Design Controls.
Education and Experience:- Bachelor's degree in Engineering, Science or related discipline.
- Minimum ten (10) years progressive experience in Quality Assurance within an FDA regulated industry.
- Minimum 3 (three) years of direct management experience of QA professional and technical staff.
- Extensive knowledge of applicable regulations and standards including 21 CFR 820, ISO 13485, ISO 14971 and ISO 10993.
- Strong understanding of design quality assurance.
- Manufacturing and project management experience is desirable.
- Knowledge of DFSS, Six Sigma Green Belt or Black Belt are desirable. Excellent communication, technical writing and leadership skills.
- Experience in applying Quality Engineering tools, statistics and problem-solving methodologies.
Knowledge and Skills:Design Control Change Control Risk Management - ISO 14971 Process Validation, Design Verification & Design Validation Identification of CTQs Unit Quality Independent Reviewer During Design Reviews Handling of Deviations and Non-Conformances Test Method Validations Supplier Qualification Post Market Surveillance and Situation Analysis CAPA and Root Cause Investigation Statistical Analysis Strong strategic planning and prioritization skills Ability to lead and influence in a matrixed, global organization.
Primary Work LocationUSA CA - San Diego Bldg A&B
Additional LocationsWork ShiftAt BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."
Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.
Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.
Salary Range Information$131,600.00 - $210,500.00 USD Annual
