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Quality Manager Post Market Surveillance - $10,000 Hiring Bonus

Quality Manager Post Market Surveillance - $10,000 Hiring Bonus

  • 2022-30997
  • Hercules, California, United States

A Snapshot of Your Day:

Bio-Rad Laboratories is seeking a Quality Manager - Post Market Surveillance to join the global QA team to lead the development, governance and management of post market surveillance activities supporting Post Market Surveillance (PMS) and Post Market Performance Follow-Up (PMPF) in accordance with ISO 13485, 21 CFR Part 820, EU IVDR, MDSAP and other regional regulations.

This position is eligible for a $10,000 HIRING BONUS

  • Bonus offered for a limited time only.
  • Bonus applicable to specific positions as labeled.
  • Bonus recipients must be employed at the time of payout.
  • Bonus payout after 30 days of employment with Bio-Rad.
  • Bonus offered to direct hires only. Agency hires and internal transfers are not eligible.
  • 12 months repayment clause.

How You’ll Make an Impact:

  • Lead a global cross functional team gathering, analyzing and reporting product post market information including complaints, field actions, clinical performance and safety data for Bio-Rad’s In-vitro diagnostics products (IVD).
  • Ensuring Post Market Surveillance (PMS) plans are aligned with product technical file submissions and applicable post market tracking and trending procedures depending on product classifications.
  • Developing and maintaining product Post Market Surveillance Plans and Reports by gaining cross functional alignments and approval.
  • Collaborate with business partners to continually assess existing PMS support processes to identify gaps and areas of improvement, create interim and future state process solutions and monitor implementation activities to ensure compliance to applicable regulatory requirements (EU IVDR, ISO 13485, 21 CFR Part 820, MDSAP and others). This includes working with software system owners and IT to identify new and/or improvements to existing systems and tools to improve data collection and reporting.
  • Act as Person Responsible for Regulatory Compliance (PRRC) under EU IVDR for post market surveillance activities.
  • Act as subject matter expert for Post Market Surveillance requirements and provide support during inspections by regulatory authorities.
  • Design, develop, implement, maintain and continuously improve related processes and global procedures to ensure compliance with applicable internal and external quality and regulatory requirements including identification, management and escalation of identified issues and risks to appropriate business partners and senior management.
  • Act as owner of global procedures related to Post Market Surveillance including ensuring global business partners are trained and aware of requirements impacting their support of PMS activities.
  • Responsible for day to day operations of the post market surveillance activities including developing and maintaining a global schedule of PMS, PMPF and PSUR deliverables, allocating resources to support activities and coordinating with business partners on needed support to achieve reporting timelines. Generate and maintain PMS plans and reports.
  • Present PMS program performance and health to management (product review meetings, Management Reviews and business review meetings) and escalate critical issues and risks to senior management.
  • Initiate and support corrective or preventive actions (CAPA) actions and updates to product risk management files as needed.
  • Maintain awareness of new and/or revised regulations, standards and guidance documents that pertain to post market surveillance activities.
  • Recruit, develop and manage a global staff.

What You Bring: 

  • Bachelor’s degree or equivalent in a scientific or engineering discipline.
  • 8+ years’ relevant quality systems experience with supervisory experience, or equivalent combination of education and experience.
  • Experience working in the medical device, pharmaceutical or other regulated industry. Thorough knowledge of medical device/drug/biotech manufacturing process and experience with risk management regulations and standards, including FDA 21 CFR 820, MDSAP, IVDR, ISO 13485 and ISO 14971.
  • Experience as a GMP and/or ISO trainer is highly desirable.
  • Experience working in a global organization and/or interfacing with multiple manufacturing locations a plus.
  • Quality Engineer, Quality Manager, Six Sigma Green Belt or Black Belt desirable.
  • Communication, public speaking, decision-making under stressful conditions, word processing, and spreadsheet and negation skills required.
  • Successful candidates will actively seek interaction with others, under potentially challenging time pressures, in order to resolve difficult technical issues. 
  • Ability to self-prioritize and manage several urgent high profile projects at once while remaining customer oriented and goal focused.

Location: Headquarters - Hercules, CA.

 

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. 

 

Benefits: We’re proud to offer a variety of options, including competitive medical plans for you and your family, free HSA funds, a new fertility offering with stipend, group life and disability, paid parental leave, 401k plus profit sharing, an 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.

 

Compensation: The estimated base salary range for this position is $101,600 to $174,700 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.

 

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.

 

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. #LI-PB1

 

 

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