Head of Quality Assurance

Company: USLA BioLegend, Inc.
Location: San Diego
Posted on: April 18, 2024

Job Description:

Head of Quality Assurance page is loaded Head of Quality Assurance Apply locations San Diego time type Full time posted on Posted 2 Days Ago job requisition id JR-038614 Job Title Head of Quality Assurance
Location(s) San Diego About Us Revvity is a developer and provider of end-to-end solutions designed to help scientists, researchers, and clinicians solve the world's greatest health challenges. We pair the enthusiasm of an industry disruptor with the experience of a longtime leader. Our diverse team of 11,000+ colleagues from around the globe are vital to our success and the reason we're able to push boundaries in pursuit of better human health. Find your future at Revvity - BioLegend (a division of Revvity, Inc.) strives for continuous improvement and future growth, we seek an experienced, passionate, and dynamic Director to oversee all Quality Assurance functions. We are looking for someone who is organized, committed, and passionate about the job, and someone who possesses clear communication skills in all aspects. In this role, you will have a hands-on role in defining, deploying, and leading organizational, process, and product quality requirements throughout the total product life cycle to fulfill the applicable global requirements. Your main functions will be to improve patient outcomes, meaningfully impact the company's short-term and long-term success work closely with executives across the organization, play an active role in how this position contributes to the overall company strategy, learn about new innovative technologies, and utilize our collaborative company culture to create an inspiring and productive workplace.Essential FunctionsReasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Responsible for Continuous Improvements of the BioLegend Quality Management System including: Management Review, Change and Document Control, Records Management, Validations, Audit and Inspection Management, Corrective and Preventive Action Management, Complaints, Failure Analysis, Risk Management per total product life cycle, Nonconformance Management, Distribution Quality, Supplier Quality, and Manufacturing Quality
• Serve as the Deputy Management Representative per ISO 13485 requirements.
• Work closely with Productions for batch reviews and product release as needed.
• Support the Process Owners, Operations Engineering team, and Facility for the required Validations and Verifications with required records.
• Provide Quality Management System training to all employees and capture the required training records with traceability.
• Work collaboratively with Regulatory Affairs and Research and Development regarding Product Development (Design) Controls, Design Assurance, and Labeling Control
• Ensure effective implementation of Quality Management Systems and Compliance requirements across BioLegend
• Ensure that a highly effective and motivated Quality Assurance team is in place to meet the needs of the business, including budgeting, staffing, training, performance management, and personnel development
• Guide manufacturing and design groups with Quality Systems and Compliance interpretation, establishment, and maintenance
• Develop a strong working relationship with internal partners to ensure compliance with regulatory requirements, and provide appropriate quality support across all business units
• Prepare, present, defend, and manage the Quality and Compliance departmental budget and staff.
• Interface with government authorities regarding Quality System and Compliance issues
• Monitor the activities of government regulatory authorities on a worldwide basis to ensure that the business is able to align with, comply with, and anticipate changes
• Lead team for the due diligence and integration activities as needed
• Other duties as assignediACT Competencies
  • innovate - Be better, keep improving, be more efficient, creative, and be in the forefront of development
  • Aspire - Have desire, purpose, and ambition challenging ourselves to push the limits and reach new heights
  • Collaborate - Foster teamwork, common goals, selflessness, communication and mutual support
  • Transform - Adapt, learn, re-invent and change for future development and growthMinimum Qualifications - Education and Experience
    • Bachelor of Science degree in biological or scientific discipline
    • A minimum of 12 years of related experience in the medical device and/or diagnostics industry
    • 6 years of people management experience
    • High energy, results-oriented leader with excellent collaboration and eQMS experience
    • Ability to utilize sound judgment and decision-making capabilities in technical, business, and regulatory compliance arenas
    • Strong expertise in domestic and international regulatory compliance requirements (e.g. FDA QSR, ISO/EN standards, and MDSAP)
    • Possess a deep Quality Engineering toolbox including Design of Experiments, Process Capability Studies, Failure Mode and Effects Analysis, Statistical Process Control, Design for Six Sigma, Industrial Statistical Methods, Six Sigma and/or Lean Manufacturing
    • Experience leading internal audit programs and managing external inspections/audits (e.g. FDA, Competent Authorities, Notified Bodies)
    • Experience dealing with government regulatory bodies, Competent Authorities, and Notified Bodies
    • Ability to effectively interface with stakeholders internally and externallyPreferred Qualifications - Education and Experience
      • Certified Quality Auditor or equivalent
      • Experience moving from a paper-based eQMS system to an electronic-based system
      • Familiarity with global quality management systems and regulatory requirements
      • Master of Science degree in Business, Engineering, or a related scientific or technical discipline
      • Lean, Six Sigma, or Kaizen experienceThe base salary range for this full-time position is $165,000-$185,000/year. This range reflects the minimum and maximum target for a new hire in this position. The base pay actually offered to the successful candidate will take into account internal equity, work location, and additional factors, including job-related skills, experience, and relevant education or training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process. -Please note that base pay is only one part of our total compensation package and is determined within a range. This range allows for the successful candidate to have an opportunity to progress within the position and develop at our company. This base pay range does not take into account bonuses, equity, or other benefits which may be applicable and are dependent on the level and position offered.Work Environment & Physical Demands - OfficeWhile performing the duties of this job, the employee regularly works in an office setting. Occasional exposure to a laboratory and warehouse environment.The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.While performing the duties of this job, the employee is regularly required to use hands and fingers to handle, feel, or operate objects, tools or controls, and reach with hands and arms. The employee is frequently required to stand, talk and hear. What do we offer?We provide competitive and comprehensive benefits to our employees. -Below are some highlights of our benefits:
        • Medical, Dental, and Vision Insurance Options
        • Life and Disability Insurance
        • Paid Time-Off
        • Parental Benefits
        • 401k with Company Match
        • Employee Stock Purchase Plan Learn more about Revvity's benefits by visiting our Why Revvity page.*For benefit-eligible roles only. Part-time and temporary roles may not be eligible for all benefits listed. Please reach out to your recruiter for more information Revvity is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. Revvity is committed to a culturally diverse workforce. About Us Revvity is a developer and provider of end-to-end solutions designed to help scientists, researchers, and clinicians solve the world's greatest health challenges. We pair the enthusiasm of an industry disruptor with the experience of a longtime leader. Our diverse team of 11,000+ colleagues from around the globe are vital to our success and the reason we're able to push boundaries in pursuit of better human health.
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Keywords: USLA BioLegend, Inc., San Diego , Head of Quality Assurance, Professions , San Diego, California