Quality Manager (1153514)

Location: Portland, OR

Pay

$130,000.00 USD Annually – $170,000.00 USD Annually

Responsibilities

• Lead and develop site Quality Assurance and Quality Engineering teams.
• Ensure compliance with FDA, ISO 13485, MDR, and applicable quality regulations.
• Oversee CAPA, nonconformance management, material review boards, and quality investigations.
• Support product development and manufacturing through quality planning, statistical analysis, and process controls.
• Monitor quality metrics, department objectives, training programs, and continuous improvement initiatives.
• Lead internal, customer, and regulatory audits.
• Manage product and process quality issues using formal problem‑solving methodologies.
• Partner with suppliers to improve product quality and resolve quality concerns.
• Provide leadership for validation, calibration, quality engineering, and related quality operations functions.

Qualifications

• Bachelor’s degree in Engineering, Scientific Discipline, or related field.
• 7+ years of quality leadership experience in a regulated industry, with 4 years of management experience.
• Solid background in a regulated manufacturing environment, preferably medical devices.
• Strong working knowledge of FDA Quality System Regulations, ISO 13485, MDR, and quality management systems.
• Experience leading larger quality teams (20+ members) and supporting regulatory audits.
• ASQ Certified Quality Engineer is preferred.
• Solid continuous improvement experience is preferred.
• Advanced statistical analysis and problem‑solving skills.

Benefits

• Medical, dental, and vision coverage.
• Matching 401(k) plan.
• Additional benefits package (details provided by employer).
• Relocation assistance if needed.

Great opportunity to join an amazing organization and grow within the future!