Quality Engineering Manager

Job Description

The Quality Engineering Manager will lead a team of quality engineers, technicians, and inspectors supporting the manufacturing of Class II/III medical devices. This individual will partner closely with Manufacturing, R&D, Regulatory Affairs, and Quality teams to drive process improvements, support new product introductions, and ensure compliance with quality system requirements. Responsibilities include overseeing validation activities (equipment, process, and test method), risk management initiatives, supplier quality and process control programs, CAPA investigations, customer complaint resolution, and manufacturing quality metrics.

The manager will also support regulatory inspections and audits, maintain controlled quality documentation, drive continuous improvement efforts using statistical methodologies, and develop and mentor a growing quality team.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances.

• Bachelor's degree in Engineering, Quality, Biomedical Engineering, Mechanical Engineering, or related scientific discipline
• 6+ years of Quality Engineering experience within the medical device industry
• Prior experience managing or leading direct reports
• Experience supporting validation activities including IQ/OQ/PQ, process validations, and test method validations
• Strong understanding of quality systems within a regulated medical device environment
• Experience with CAPA investigations, nonconforming products, and customer complaint management
• Experience reporting and analyzing quality metrics
• Knowledge of manufacturing quality processes and continuous improvement methodologies
• Experience working cross-functionally with Manufacturing, Regulatory, R&D, and Quality teams
• Proficiency with Microsoft Office and document management systems;
  Knowledge of ISO 13485 and FDA medical device regulations
• Experience with ISO 14971 risk management activities
• Experience managing supplier quality programs
• Experience supporting FDA, Notified Body, or ISO audits
• Strong background in statistical methodologies such as SPC, statistical sampling, Six Sigma, and root cause analysis
• Experience supporting controlled manufacturing environments (ISO 8 cleanroom)
• Excellent written and verbal communication skills
• Strong project management and organizational skills
• Medical device manufacturing experience supporting commercialized products and sustaining engineering initiatives