MedTech Quality Engineering Manager

bdx; San Diego (CA); On-site; USD 132,000 - 211,000; Full time

Job summary

BD, a global medical technology leader, seeks a Manager, Quality Engineering to shape and implement the Quality Management strategy for the WWISD Design Center. You will lead a team of Quality Engineers, ensure compliance with 21 CFR 820 and ISO 13485, and drive risk management per ISO 14971 across new product development and maintenance.

Your role ensures robust QMS, applies quality engineering tools, and coordinates with ISD Quality Leadership to sustain regulatory readiness and product

Qualifications

• Bachelor’s degree in Engineering, Science or related discipline.
• Ten years of progressive QA experience in an FDA regulated industry.
• Minimum three years direct management of QA professionals.
• Extensive knowledge of 21 CFR 820, ISO 13485, ISO 14971, ISO 10993.
• Strong design quality assurance understanding.
• Manufacturing and project management experience is desirable.
• Knowledge of DFSS and Six Sigma belts.
• Excellent communication, technical writing and leadership skills.

Responsibilities

• Lead development 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 meet quality and regulatory requirements.
• Provide Quality Engineering support and promote statistical tools in design and development.
• Lead Risk Management activities in line with ISO 14971.
• Support continuous improvement of quality and market competitiveness.
• Develop department skills 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 site and functional SME for Design Controls.

Skills

Quality Assurance

Regulatory Compliance

Leadership

Process Validation

Risk Management

Statistical Analysis

Problem Solving

Education

Bachelor’s degree in Engineering or related discipline

Tools

Quality Engineering Tools

Six Sigma Green/Black Belt

Design of Experiments

Job description

BD, a global medical technology leader, seeks a Manager, Quality Engineering to shape and implement the Quality Management strategy for the WWISD Design Center. You will lead a team of Quality Engineers, ensure compliance with 21 CFR 820 and ISO 13485, and drive risk management per ISO 14971 across new product development and maintenance.

Your role ensures robust QMS, applies quality engineering tools, and coordinates with ISD Quality Leadership to sustain regulatory readiness and product