JOB DESCRIPTION

We are seeking a Quality Assurance Manager to join our team in Carlsbad, CA. This role involves laying out policies and procedures, with 50% of the time spent at the manufacturing site in Oceanside, only 8 miles away. The individual will interface with customers regarding regulatory and compliance issues, collaborate with other groups, including the QC Manager and Supervisors, and serve as the internal auditor leading audits. Additionally, they will champion the development of other individuals to achieve internal auditor certification. The role will also include responsibilities related to new product development from a QA perspective, customer-related issues, and managing customer surveys/questionnaires, ensuring that responses are communicated effectively. Contributing to the ISO certification of the Oceanside site is also a key focus, as most customers are GMP companies, primarily in the pharmaceutical sector.

Some responsibilities of the Quality Assurance Manager will include but are not limited to:

- Laying out policies and procedures

- Customer interface regarding regulatory and compliance

- Leading internal audits and championing internal auditor certification for others

- Collaborating on new product development processes

- Handling customer complaints and investigations

- Responding to GMP customer surveys/questionnaires

- Championing the 8D investigations and communicating responses back to the customers

- Contributing to the ISO certification process for the Oceanside site

LOCATION/TRAVEL:

- 50% Carlsbad, CA and 50% Oceanside, CA (worksites are 8 miles apart)

SCHEDULE:

- Monday - Friday - 8:00 AM - 5:00 PM with occasional exceptions

TRAINING:

- On-the-job training will be provided to familiarize with company-specific policies and procedures. Ongoing education for employees will also be a part of the role's responsibilities.

REQUIRED SKILLS AND EXPERIENCE

- Senior: 3 - 5 years experience within QA in life sciences

- Manager: 3 – 7+ years' experience within QA in life sciences

- Experience in ISO 9001:2015 environment; familiarity with ISO 13485 (medical device standards) is preferred

- Proven experience performing internal audits and engaging effectively with customers/auditors

- Experience in 8D problem-solving methodology

PAY:

$90,000 - $110,000