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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 is a manufacturer and distributor of premium medical device and personal care products dedicated to enhancing consumer well-being. Our flagship offering, ASTROGLIDE, stands as a leading brand in the personal lubricant market. Based in Vista, CA, our operations encompass sales, marketing, consumer engagement, research and development, insights and innovation, quality assurance, regulatory compliance, and distribution. Despite the global reach of ASTROGLIDE, we maintain a close-knit, family-owned business atmosphere that fosters an entrepreneurial spirit.

Why Choose BioFilm?

As a dynamic organization with a growing product portfolio, BioFilm provides significant opportunities for professional advancement and personal development. Our inclusive culture is anchored by 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 opportunities
  • 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 considers various factors when determining salary offers, including the position's responsibilities and the candidate's qualifications and experience.

Role Overview

The Quality Specialist plays a crucial role in collaborating with internal stakeholders to enhance the overall Quality Management System (QMS). Responsibilities include analyzing data to identify quality trends, addressing issues, and providing actionable insights for product and process enhancements. The specialist will design, support, and implement changes aimed at improving quality and operational efficiency. This role also involves assisting with research, design transfer, and design control for new products. Furthermore, the specialist will lead risk assessments, problem-solving initiatives, and root cause analysis to effectively tackle quality challenges and promote continuous improvement throughout the organization. A strong emphasis is placed on fostering a culture of quality, continuous improvement, and exceptional customer service.

Key Responsibilities:

  1. Initiate and manage Non-Conformance Material Reports (NCMRs), Corrective and Preventive Actions (CAPAs), Supplier Corrective Action Requests (SCARs), deviations, customer complaints, and product/process investigations.
  2. Design, implement, and monitor improvements to the QMS processes.
  3. Oversee design transfer and design control activities.
  4. Conduct document reviews and manage change documentation.

Quality Commitment:

• A strong quality mindset and commitment to quality standards are essential.

• Responsible for adhering to all quality procedures and standards within the work area.

• Monitor product quality and promptly report any defects to the supervisor.

• Identify and report potential regulatory compliance issues, including cGMP conditions and quality system non-compliance.



Qualifications and Educational Background:

  • Bachelor's degree in Engineering, Chemistry, Biology, Biotechnology, Chemical Engineering, or a related scientific field.
  • 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.
  • Familiarity with regulated environments and strong knowledge of medical device FDA 21 CFR 820/ISO 13485:2016 requirements.
  • Working knowledge of 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/Statistical Sampling is preferred.
  • Formal training in statistical techniques is preferred.
  • Project management skills are preferred.


Compensation: Yearly Salary



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