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Quality Assurance Specialist

2 months ago

Chula Vista, California, United States BIO FILM INC Full time

About BioFilm Inc

Company Overview

BioFilm Inc is a prominent manufacturer and distributor of premium medical devices and personal care products, dedicated to enhancing the well-being of our customers. Our flagship product, ASTROGLIDE, stands as a leading brand in the personal lubricant market. Our corporate headquarters is located in Vista, CA, where we house various departments including sales, marketing, research and development, quality assurance, regulatory compliance, and distribution. Despite the global reach of ASTROGLIDE, we maintain a close-knit, family-owned business atmosphere that fosters innovation.

Why Choose BioFilm

At BioFilm, we are committed to growth and innovation, providing our employees with numerous opportunities for professional advancement. Our workplace culture is inclusive and is built upon core values such as Teamwork, Enjoyment, Exceeding Expectations, Integrity, Respect, Accountability, and Making a Difference. We offer a competitive compensation package that includes:

  • Four-day work weeks with Mondays off
  • Comprehensive health, dental, and vision insurance, along with Health Reimbursement Account and Flexible Spending Account options
  • 401K matching and profit-sharing plans
  • Discretionary annual bonuses based on company performance
  • Generous paid time off and holiday schedule, including time off from Christmas Eve to New Year's Day
  • Annual opportunities for professional development
  • Tuition reimbursement programs
  • This position is temporary for a duration of up to 12 months.
  • The salary range provided serves as a general guideline; BioFilm Inc considers various factors when determining salary offers, including the role's responsibilities and the candidate's qualifications.

Role Overview

The Quality Specialist plays a crucial role in collaborating with internal teams to enhance the overall Quality Management System (QMS). Responsibilities include analyzing data to identify quality trends, troubleshooting issues, and providing actionable insights for product and process enhancements. This role involves designing, supporting, and implementing changes aimed at improving quality and operational efficiency. The Quality Specialist will also assist in research, design transfer, and design control for new products. Key responsibilities include:

  1. Leading Non-Conformance Material Reports (NCMRs), Corrective and Preventive Actions (CAPAs), Supplier Corrective Action Requests (SCARs), and customer complaint investigations.
  2. Designing, implementing, and monitoring improvements to the QMS processes.
  3. Overseeing design transfer and design control activities.
  4. Conducting document reviews and managing change documentation.

Quality Commitment

• A strong commitment to quality and a quality-oriented mindset are essential.

• Adherence to all quality procedures and standards is required.

• Monitoring product quality and promptly reporting any defects to management.

• Identifying and reporting potential regulatory compliance issues, including non-compliance with quality systems.



Qualifications and Education

  • Bachelor's degree in Engineering, Chemistry, Biology, Biotechnology, Chemical Engineering, or a related scientific field.
  • A minimum of 5 years of experience in Quality Control or Quality Assurance.
  • Experience with SCAR, CAPA, NCMR, and customer complaint investigations, including root cause analysis.
  • Experience in a regulated environment with knowledge of medical device regulations, including FDA 21 CFR 820 and ISO 13485:2016.
  • Familiarity with Quality Systems and quality-related tools such as FMEA, SPC, Cpk, AQP, and DOE.
  • ASQ or Six Sigma Green/Black Belt certification is preferred.
  • Experience with AQL and statistical sampling is preferred.
  • Formal training in statistical techniques is preferred.
  • Project management skills are preferred.


Compensation: Yearly Salary