Manager Quality Engineering

$95,000 - $190,000/Yr

Abbott Laboratories - Tigard, OR

Full-time - Mid Level

Tigard, OR

10,001+ employees

Miscellaneous Manufacturing

About the position

This position is responsible for developing, establishing, and maintaining quality assurance programs, policies, processes, procedures, and controls to ensure that the performance and quality of products conform to established standards and agency regulations. The role involves providing leadership in quality engineering, managing teams, and ensuring compliance with quality regulations in the medical device manufacturing sector.

Responsibilities

• Provide Quality Engineering leadership in direct support of medical device manufacturing.
• Manage the activities of the Post-Production Quality Engineering team.
• Define and implement superior Process Control & Monitoring systems for KPIV and KPOV throughout the product lines.
• Identify opportunities to proactively assure compliance with internal and international quality regulations.
• Lead cross-functional teams to complete Quality Initiatives.
• Maintain effective Quality Metrics and define activities to resolve performance decreases.
• Support Divisional initiatives in alignment with Quality Management Systems (QMS) and Environmental Management Systems (EMS).
• Hire and retain a diverse, highly qualified staff and provide ongoing performance feedback.
• Communicate effectively with all levels of employees, customers, contractors, and vendors.

Requirements

• B.S. in Engineering degree (Mechanical, BioMedical, Materials, or Manufacturing Engineering).
• 8 years of experience in Class III or II medical device manufacturing.
• 3 years of experience in a supervisory/leadership role.
• Strong analytical, written, and verbal communication skills.

Nice-to-haves

• Experience with FDA design controls for medical devices (ISO/GMP).
• Industry experience with medium to high-volume manufacturing.
• Experience working in a broader enterprise/cross-division business unit model.

Benefits

• Competitive salary range of $95,000.00 - $190,000.00 based on experience and location.