REQUIREMENTS:

• Bachelor’s degree in Life Sciences, Engineering, or a related field. (A combination of education and experience will be considered for this position.)
• Minimum of 3-5 years of experience in a quality role within the pharmaceutical, biotechnology, or medical device industry.
• Strong knowledge of GMP, ISO, and regulatory requirements related to CAPA, stability programs, environmental monitoring, and validation.
• Experience with quality management systems (QMS) and electronic documentation platforms.
• Strong communication and leadership abilities, with experience managing cross-functional teams. Excellent problem-solving, analytical, and organizational skills.
• Ability to communicate effectively both orally and in writing and to establish and maintain productive working relationships.
• Ability to exercise independent judgment consistent with Company guidelines.
• Certified Quality Auditor (CQA) or equivalent certification preferred.
• Experience in conducting audits (supplier and/or internal), supplier qualification assessments, and supplier corrective action management.

ADDITIONAL SKILLS:

• Ability to independently develop and manage projects and timelines
• Ability to communicate effectively both orally and in writing and to establish and maintain productive working relationships
• Strong attention to detail and process mindset
• Ability to exercise independent judgment consistent with Company guidelines
• Excellent verbal and written communication skills.
• Familiar with statistical process control methods.

PHYSICAL REQUIREMENTS

• Ability to hear and speak to employees and external associates on the phone and in person.
• Ability to see the letters and numbers on a personal computer screen and on memos, reports and other documents (near vision)
• Ability to walk and/or drive between buildings on campus, up to .3 miles for San Diego based positions

TRAVEL REQUIREMENTS

• May require travel to and from Nucleus Biologics offices or customer/vendor locations based on position.

ABOUT THE ROLE

The Quality Engineer is responsible for ensuring compliance with regulatory requirements (i.e. ISO 9001, ISO 13485 and EXCiPACT) and internal quality standards. This role oversees key quality programs, including Supplier Quality, CAPA, NCR, Complaints, and OOS investigations, as well as managing site audit readiness. Additionally, the Quality Engineer provides Operation Excellence support and drives continuous improvement initiatives.

NOTE: THE ABOVE STATEMENTS ARE INTENDED TO DESCRIBE THE GENERAL NATURE AND LEVEL OF WORK BEING PERFORMED BY INCUMBENTS. THEY ARE NOT INTENDED TO BE AN EXHAUSTIVE LIST OF ALL RESPONSIBILITIES, DUTIES AND SKILLS REQUIRED BY ALL INCUMBENTS. INCUMBENTS MAY PERFORM OTHER DUTIES AS ASSIGNED. REASONABLE ACCOMMODATIONS MAY BE MADE TO ENABLE INDIVIDUALS WITH DISABILITIES TO PERFORM THE ESSENTIAL FUNCTIONS. MANAGEMENT RETAINS THE RIGHT TO ADD TO OR CHANGE THE DUTIES OF THE POSITION AT ANY TIME.

The pay range for this role is:
70,000 - 80,000 USD per year(San Diego, CA