Senior Quality Engineer - MedTech Design Controls

BD; San Diego (CA); On-site; USD 137,000 - 169,000; Full time

Job summary

BD in San Diego (USA) seeks a core team quality representative for design control projects, leading verification and validation, risk management, and regulatory support to ensure products meet QMS and are ready for market. You will collaborate with program managers, drive root cause analysis, maintain Design History Files, and promote continuous improvement across design and manufacturing.

A Bachelor’s degree in engineering with 3 years of related experience is required, with salary range

Qualifications

• Bachelor’s degree in Engineering (any), Information Technology, Information Systems, Computer Science or related field and three years of related experience.
• Experience with regulatory standards (21 CFR 820, ISO 13485, ISO 14971, IEC 62304) and quality engineering tools.
• Knowledge of software verification and validation in regulated environments and SAFe.

Responsibilities

• Lead design control quality activities including planning, verification, validation and risk management.
• Review artifacts for QMS compliance and ensure traceability of design data.
• Collaborate with program managers to ensure products can be released in defined markets.
• Drive root cause analysis and continuous improvement across design and manufacturing.

Skills

Quality engineering

Regulatory compliance

Risk management

Root cause analysis

Software V&V

SAFe

Education

Bachelor’s degree in Engineering or related field

Job description

BD in San Diego (USA) seeks a core team quality representative for design control projects, leading verification and validation, risk management, and regulatory support to ensure products meet QMS and are ready for market. You will collaborate with program managers, drive root cause analysis, maintain Design History Files, and promote continuous improvement across design and manufacturing.

A Bachelor’s degree in engineering with 3 years of related experience is required, with salary range