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.
#J-18808-Ljbffr
Keywords: USLA BioLegend, Inc., Encinitas , Head of Quality Assurance, Professions , San Diego, California
Didn't find what you're looking for? Search again!
Loading more jobs...