Confidential - Bilingual Quality Manager

An employer in the lab consumables/disposables manufacturing industry is looking for a Bilingual Sr. QA Specialist or Bilinguals Quality Assurance Manager to join their team. 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 Sr. QA Specialist or 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

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. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

Senior: 3- 5 years' experience within QA in life sciences
- Manager: 5 – 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
-Bilingual in Spanish & English

- Internal auditor certification is a significant advantage
Background in GMP or GxP environments is preferred - Preference for candidates who have advanced through the ranks in their career

Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.