Associate Director, Quality Management System
Company: bioM--rieux SA
Location: San Jose
Posted on: May 27, 2023
Associate Director, Quality Management System The estimated
salary range for this role based in California is between $165,200
and $198,200 annually. This role is eligible to receive a variable
annual bonus based on company, team, and individual performance per
bioMerieux's bonus program. This range may differ from ranges
offered for similar positions elsewhere in the country given
differences in cost of living. Actual compensation within this
range is determined based on the successful candidate's experience
and will be presented in writing at the time of the offer.
- A choice of medical (including prescription), dental, and
vision plans providing nationwide coverage and telemedicine
- Company-Provided Life and Accidental Death Insurance
- Short and Long-Term Disability Insurance
- Retirement Plan including a generous non-discretionary employer
contribution and employer match.
- Adoption Assistance
- Wellness Programs
- Employee Assistance Program
- Various voluntary benefit offerings
- Parental leaves The world is facing a medical crisis, bacteria
are increasingly evolving resistance to even our strongest
antibiotics. The problem is already very real and immediate; for
example, bloodstream infection leading to sepsis is now responsible
for more than half of all deaths in hospitals and is the most
expensive condition treated in hospitals. Sepsis mortality rate
increases > 6% every hour without effective antibiotic
treatment. Yet, despite the life and death urgency, and healthcare
cost impacts, current methodologies require 3 days to determine the
correct antibiotic. Specific Diagnostics, a bioM--rieux company,
has developed a breakthrough solution to rapidly determine the
effective antibiotic treatment for bloodstream and other acute
infections. Used for bloodstream infection Specific's solution
provides results 2 days sooner than existing methods, saving
patients suffering from drug-resistant.
- Serve as the backup Site Quality Management Representative, for
the manufacturing facility and lead assessments of the Quality
Systems for compliance (e.g. customers, FDA, ISO Registrars), and
ensure that such assessments are conducted in accordance with
established policies and procedures to maximize their benefit to
- Lead or facilitate teams to accomplish the deliverables,
milestones, and objectives meeting the plans and schedules ensuring
that any changes are communicated and agreed to by the teams and
project sponsors for the St. Louis site. This includes teams to
standardize processes at North America sites to ensure the North
America ISO 9000 & 13485 registration is maintained.
- Lead or support the execution of the site Quality Management
Review and Internal Audit Program and implementation of the
Corporate Quality Manual, directives and processes.
- Develop and maintain the Corrective and Preventive Action
programs including necessary procedures, records, manuals, and
- Develop and maintain the customer complaint trending and
compliant investigation processes including necessary procedures,
records and reports. Ensure the timely response and closure of
complaint investigations and provide oversight of complaint
- Recruit and develop employees who will function well within our
corporate culture. Evaluate and direct employees to ensure job
satisfaction and improvement. Encourage staff to take initiative,
be proactive, and strive to improve their work and the processes
that shape their work.
- Configuration control and management of all documentation and
data required to manufacture products produced and distributed from
the St. Louis, MO. This includes the Device Master Indexes and the
assignment and maintenance of Part Numbers and Bill Of Materials
(BOM) in SAP. Assure that this documentation meets the requirements
of 21CFRPart 820 Quality System Regulation, In-Vitro Diagnostic
Directive and other country specific language requirements.
- Develop and implement Quality and Compliance training programs
that provide necessary organizational knowledge to achieve company
and regulatory objectives including compliance.
- Establish, maintain, and improve reports of quality data such
as customer satisfaction, business level quality, and functional
area quality indicators to assist the continuous improvement of
quality and analyze them to assess the effectiveness of both the
company quality system.
- Manage site compliance projects as needed.
- Manage and adhere to department budget. KNOWLEDGE, EXPERIENCE &
- Requires a Bachelors Degree in scientific field, Masters Degree
- Requires a minimum ten (10) years progressively responsible
quality systems experience in an FDA regulated manufacturing
environemnt (such as medical device).
- Must have a expert knowledge in the interpretation and
application of relevant Domestic and International Regulations and
Industry Standards (ISO, QSR, UL, CSA, VDE, etc.).
- Requires a minimum of 5 years experience managing quality teams
and leading people.
- Must possess strong interpersonal, written and oral
- Certification in one of the following is desired: CQE, CQA,
CBA, CMQ/OE, or Six Sigma Black Belt.
Keywords: bioM--rieux SA, San Jose , Associate Director, Quality Management System, Executive , San Jose, California
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