Quality Engineering Manager

Becton Dickinson Medical Devices•San Diego, CA

6d•Onsite

About The Position

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.

Requirements

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.
Excellent communication, technical writing and leadership skills.
Experience in applying Quality Engineering tools, statistics and problem-solving methodologies.
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.

Nice To Haves

Manufacturing and project management experience is desirable.
Knowledge of DFSS, Six Sigma Green Belt or Black Belt are desirable.

Responsibilities

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.