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Quality Engineer III

Quality Engineer III

  • 2023-31153
  • Hercules, California, United States

Bio-Rad is seeking an experienced Quality Engineer to join the Northern California Quality Assurance team to support design and change control, post market surveillance activities, CAPA and complaint investigations, risk management file creation & updates and support of current and new product development. risk files to align with ISO 14971:2019 and IVDR as well as product DHF documentation support. Each week this position remains open is additional backlog for these critical deliverables.

The Quality Engineer will play a key role in supporting product development teams, risk management, post market surveillance, complaint and CAPA programs for Life Science (LSG) and Clinical Diagnostics (CDG) products.

How You’ll Make An Impact:

  • Work with product design teams, regulatory affairs, clinical affairs, marketing and other relevant stakeholders to ensure appropriate quality requirements are defined and meet applicable regulatory requirements and international standards. 
  • Applies design control and quality engineering techniques to ensure design control, risk management and test requirements are fulfilled. 
  • Work with design and manufacturing teams to transfer design requirements into manufacturing to optimize manufacturability and control scrap. 
  • Conducts independent review of design history files (DHF) and technical files. 
  • Leads and/or facilitates risk management and post market surveillance activities including maintaining risk management files. 
  • Leading cross functional teams in risk planning, analysis, control and mitigation. 
  • Leads and facilitates Risk Management Board. 
  • Compiling and analyzing information to identify unacceptable trends and benefit-risk conclusions with the goal of driving suitable corrective actions needed to maintain safe and effective products. 
  • Contributing to and/or reviewing health hazard analyses and product risk assessments for issues potentially impacting patient outcomes. 
  • Assessing technical product and QMS documentation such as test protocols, reports, manufacturing procedures, complaints, nonconformances, CAPA, change orders, etc. 
  • Assess and update, as required, product risk management files related to the change control, manufacturing process control, design control, complaint and CAPA programs. 
  • Support, manage and/or lead CAPA and complaint investigations as required. 
  • Mentoring peers and lower level Quality Engineers in the application of Design Control, Risk Management and Post market Surveillance requirements and industry best practices. 
  • Assisting RAQA leadership with communication of Risk Management and Post Market Surveillance program status and needs to executive management team members. 
  • Supporting a wide range of continuous and process improvement initiatives, including creating process flow maps, procedures and training materials. 
  • Support other quality and compliance activities as required including supporting regulatory submissions, audits and inspections. 
  • Help to drive and foster a quality environment and mindset throughout the business.

What You Bring:

  • Bachelor’s degree or equivalent in Biology, Chemistry, or related field. 
  • 3+ years’ experience in a regulated manufacturing industry or equivalent combination of education and experience. 
  • Full knowledge of and application of Quality Engineering and Risk Management required. 
  • Thorough understanding of GMP/ISO regulations (ISO 14971, ISO 13485, IEC 62366, MDSAP, IVDR and FDA 820/210/211). 
  • Detail-oriented, excellent organization and project management skills are needed to meet expectations. 
  • Decision making, time management, communication, leadership, and computer skills. 
  • SalesForce, SAP and Power BI experiences, Six Sigma Green or Black Belt certification is a plus.

Vaccination Requirement: Ability and consent to upload proof of completed Covid-19 vaccination into our secure database within 3 days of start date.  

 

Total Rewards Package: At Bio-Rad, we’re empowered by our purpose and recognize that our employees are as well. That’s why we offer a competitive and comprehensive Total Rewards Program that provides value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Bio-Rad's robust offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee’s work and life cycle.

 

Who We Are: For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Recently voted a Best Place to Work, Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see.  

 

Benefits: Bio-Rad's biggest asset is its people, and the reason why our Total Rewards deliver programs that provide value, quality, affordability, and inclusivity while satisfying the diverse needs of our evolving workforce. Our robust offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee’s work and life cycle. We’re proud to offer rich options, including no-cost medical plans, free HSA money, a new fertility offering with stipend, life and disability, paid parental leave, 401k plus profit sharing, employee stock purchase program, a new upgraded and streamlined mental health platform, extensive learning and development opportunities, education benefits, student debt relief program, pet insurance, wellness challenges, time off, ERG’s, and more!  

 

Compensation: The estimated base salary range for this position is $99,700 to $137,100 at the time of posting. Actual compensation will be provided in writing at the time of offer, if applicable, and is based on several factors we believe fairly and accurately impact compensation, including geographic location, experience, knowledge, skills, abilities, and other job permitted factors. This position is eligible for a variable annual bonus, which is dependent upon achievement of your individual objectives and Company performance.

 

EEO Statement: Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with disabilities, and people of all races, ethnicities, genders, ages, and orientations are encouraged to apply.  

 

Agency Non-Solicitation: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.

 

 

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