Senior Quality Manager

The Quality Manager will be responsible for implementing and maintaining an effective quality management system for the Singapore discrete manufacturing site that complies with Medical Device Single Audit Program (MDSAP) requirements.  This individual will function as a senior leader who collaborates with other functional managers to establish strategic quality plans and lead the organization as a change agent in building a culture of quality and compliance.  The candidate must demonstrate excellent leadership, communication, critical thinking, judgement and organizational skills.   It is expected that this position will lead a team-based organization in a matrix environment where employees are flexible and empowered to make decisions appropriate for their level.  

How You’ll Make an Impact:

• Develop, implement and maintain effective and MDSAP compliant quality system processes.
• Develop and lead quality assurance function/team and QMS strategic quality planning processes.
• Collaborate with other GSC sites, local functions, R&D teams and QA organizations to determine approaches to achieve local and global quality objectives.
• Oversee ongoing collection, analysis and communication of QMS performance data. Ensure reporting aligns with global corporate measures.
• Promote use of risk-based approaches to support transfer and manufacturing activities. Lead by example to use of sound investigation and corrective action methods and statistical techniques.  Guide and approve CAPA risk assessments, correction, containment and communication in response to identified performance issues.  
• Communicate quality-related regulatory requirements to the management team and greater organization.
• Serve as Senior Management Representative for the Quality Management System ensuring the QMS is effective and meets customer and regulatory requirements.
• Serve as QA/RA contact with outside regulatory agencies and other external parties during inspections and audits.

What You Bring:

While this list of qualifications may help an employee to succeed in this position, capable candidates may have a wide range of backgrounds or skills. If you have experience that aligns with the responsibilities of this role, we encourage you to apply.

• Bachelor’s degree in Engineering, Biology, Chemistry, or related discipline. Advanced degree preferred.
• Certified as an ISO 13485 lead auditor is highly desirable.
• Quality Engineer, Quality Manager, Six Sigma Green or Black Belt Certification desirable.
• Relevant medical device industry and quality systems experience in a regulated environment (MDSAP, GMP and/or ISO 13485).
• Thorough understanding of MDSAP and ISO standards as they apply to products manufactured by Bio-Rad
• Experienced in hosting regulatory inspections is required.
• Project management, change management, organizational, interpersonal, and leadership skills are essential
• Skilled in statistical methods, statistical process control and sampling plans
• At least 12 years’ relevant experience with supervisory experience, or equivalent combination of education and experience in a regulated environment.
• Implementation of MDSAP and ISO 13485 is required.
• Minimum of 2 years of experience working with ERP (enterprise resource planning) systems such as SAP or Oracle, as well as experience with Product Life Cycle Management (PLM).
• Experience with risk management regulations and application
• Experience performing, writing, and approving failure investigations
• Experience approving DHF, validation protocols and risk management files
• Experience supervising/ managing a quality systems program in a regulated environment

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 our people, and this is the reason why our Total Rewards deliver programs that provide value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Our 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 comprehensive medical plans and insurance, flexible benefits, wellness programs, extensive learning and development opportunities and more.

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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Legal Entity: (SGP_3000)Bio-Rad Laboratories (Singapore) Pte Ltd