Quality Specialist

Company: BIO FILM INC
Location: Vista
Posted on: September 1, 2024

Job Description:

Description: BioFilm Inc is Hiring!!
Who We AreBioFilm manufactures and distributes high-quality medical device and personal care products that contribute to the well-being of our consumers. Our flagship product, ASTROGLIDE, is one of the world's leading personal lubricant brands. Our headquarters, in Vista, CA is home to sales, marketing & consumer engagement, research & development, insights & innovation, quality control, regulatory affairs, and distribution. Although ASTROGLIDE is a global brand, we are a small, private, family-owned company with an entrepreneurial spirit.
Why Work HereBioFilm is a growing company with an expanding product line, offering ample opportunity for professional growth and development for employees. Our culture is inclusive and guided by our core values of Teamwork, Have Fun, Exceed Expectations, Do the Right Thing, Respect, Accountability, and Make a Difference. Our competitive compensation includes the following excellent benefits:

• 4-day work weeks - every Monday off!
• Full health, dental, and vision insurance plus Health Reimbursement Account and Flexible Spending Account options available
• Matching 401K and profit-sharing
• Discretionary annual bonuses based on profits
• Generous PTO and holiday schedule including paid time off from Christmas Eve to New Year's Day
• Annual professional development opportunities
• Tuition reimbursement
• This role is a temporary role for up to 12 months.
• The salary range listed represents a general guideline; however, Biofilm, Inc considers a number of factors when determining base salary offers such as the scope and responsibilities of the position and the candidate's experience, education, skills and current market conditions.
  Our Quality Specialist collaborates with key internal stakeholders to enhance the performance of the overall Quality Management System (QMS). They analyze data to track quality trends, identify issues, and offer actionable insights for product and process improvements. They design, support and implement changes to boost quality and operational efficiency. Assist with research, design transfer, and design control for new products. Additionally, they lead risk analysis, problem-solving, and root cause analysis efforts to address quality issues effectively and drive continuous improvement across the business. Promotes a culture of quality, continuous improvement, and outstanding customer service.
  1. Initiated and Drive NCMRs, CAPAs, SCARs, Deviations, customer complaints, product/process investigations and systems. 2. Design, implement , and monitor QMS process improvements3. Design transfer/ Design Control 4. Document Review / Change Review. Document changes
  Quality - A quality mindset and commitment to Quality are required - Responsible for following all quality procedures and standards in work area - Monitor product quality and flag any defects immediately to supervisor - Identify and report potential regulatory compliance issues (lack of cGMP conditions, quality system non-compliance, etc)Requirements:
  QUALIFICATIONS AND EDUCATION REQUIREMENTS:
  
  • BS in Engineering, Chemistry, Biology, Biotech, Chemical ENG, or other Science Related Field
  • 5+ years of Experience in Quality Control/Assurance
  • SCAR, CAPA, NCMR, and Customer Complaint Investigation and Root Cause Analysis experience Required.
  • Experience working in a regulated environment with a 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, DOE.
  • ASQ or Six Sigma Green/Black Belt certification is preferred.
  • AQL/Statistical Sampling experience is preferred.
  • Formal training/course work in statistical techniques is preferred.
  • Project Management skills Preferred.
    
    
    Compensation details: 85000-100000 Yearly Salary
    
    
    
    PIa3af4a6205e1-37248-35370199

Keywords: BIO FILM INC, Vista , Quality Specialist, Other , Vista, California