Sr. Quality Assurance Manager
Company: Regional Recreation Corporation of Wood Buffalo
Posted on: February 23, 2021
All trademark and product names are trademarks of Cantel Medical
Corp., its affiliates and related companies. OLYMPUS--, PENTAX--,
FUJIFILM---, STORZ--, and WOLF-- are trademarks of their respective
owners. HuFriedyGroup is the dental industry leader in infection
prevention solutions, premium instrumentation, and service and
support programs that help dental professionals be the best in
practice. As the dental division of Cantel, HuFriedyGroup
encompasses a vast array of brands and products, integrated
together to deliver full service and support - a complete circle of
protection - to dental practices around the globe. We are dedicated
to employee engagement and development, diversity and inclusion,
wellness, and social responsibility. Our core values and
well-defined culture are evident in daily life at HuFriedyGroup and
continue to shape the success of our business. Visit us at
www.hu-friedy.com-- #CB About the role The Sr. Quality Assurance
Manager will be based at our Palmero Healthcare facility and
ensures that the quality of the company's products and services
meet the requirements, specifications and quality standards
established by the customer, company and applicable regulatory
bodies. Manages Palmero and J&J quality objectives.
Participates in new supplier approvals. Supports the corrective and
preventive process, both internal and external (i.e. suppliers).
Uses engineering principles to provide continuous process
improvement. Manage quality inspection team. This role requires
strong knowledge of ISO 13485, 21 CFR 820, and EU Medical Device
Regulations, as well as U.S. EPA regulations. Working knowledge of
ISO 9001 (current edition), preferred. #CB What you will do
- Manage all acceptance activities (incoming inspection, final
release inspection, in-process inspections, first article
inspections, etc.) performed by the Quality team, assuring that
these activities are properly performed and documented. *
- Assure that quality activities performed by other functions
(e.g., in-process or final inspections performed by manufacturing,
equipment and process validations, etc.) follow approved procedures
and are performed by adequately trained personnel. *
- Lead inspector(s) and train new inspectors. *
- Run reports, locate and organize daily work, as applicable.
- Coordinate and resolve local Material Review Board issues in a
timely manner. *
- Drive quality improvements using solid engineering tools such
as SPC, Lean, Six Sigma, DMAIC problem solving and report on status
as necessary. Evaluate new inspection equipment, techniques and
- Oversee local calibration system and ensure all instruments,
materials, written procedures, etc., used in inspection process are
- Assure that the quality system is designed and implemented such
that certifications will be maintained; assure that proper
communication with senior management is maintained; coordinate data
collection for periodic Management Reviews.
- Assist in assuring that Quality System documentation is kept up
to date; control changes to the Quality Manual; review/approve
changes to Operating Procedures; review and approve Risk Assessment
Reports, Essential Requirements Checklists, Design Requirements
documents, Design Verification/Validation documents.
- Ensure equipment, software, and process validation activities
are implemented per the quality managementnsystem
- Facilitate the local implementation of global UDI requirements
for the products within the applicable compliance timeframe.
- Lead external regulatory agency, Notified Body or customer
audits for the Palmero Healthcare and J&J Instruments
- Support Corrective and Preventive Action (CAPA) System
- Support supplier quality audits and serve as Internal Audit
- Ensure standards are set for control of raw material.
- Achieve financial objectives identified through budget and
senior quality leadership
- Maintain up-to-date professional and technical knowledge and
ensure compliance with local regulations and standards including
compliance with all applicable Food & Drug
- Administration (FDA) and European Union Medical Device
Regulation (MDR) as well as other applicable global regulatory
requirements (i.e. U.S. EPA) that impact the devices produced by
Palmero Healthcare and J&J Instruments.
- Teach, govern, and lead efforts that proactively ensure Quality
Assurance for Palmero Healthcare's and J&J Instruments'
- Complete other responsibilities, as assigned. What we are
looking for Functional Knowledge, Skills & Abilities
- A bachelor's degree in technical field (Quality Engineering,
Mechanical or Biomedical Engineering, or Metallurgical Engineering)
preferred. Equivalent work experience accepted.
- A minimum of 7 years of experience in Quality
Assurance/Control. Medical device/FDA experience required.
- Knowledge of process and/or product validation concepts and
- Excellent management skills. Strong people management/coaching
and development experience.
- Excellent team player/leader.
- Demonstrates skill at multi-tasking and resourcefulness.
Ability to efficiently participate simultaneously in multiple
- Demonstrates skill at managing by influence and completing
tasks through others in non-reporting relationships.
- Good presentation and training skills for both internal and
- Strong analysis & problem-solving skills
- Strong written and oral communication skills, exceptional
listening skills. *
- Computer literate (especially spreadsheets, databases, and
presentation software) and the ability to use communications tools,
such as email, web-conferencing systems, etc.*
- Previous SAP experience preferred. Working Conditions/Physical
- General office conditions apply. Sitting, standing, very little
lifting (less than 10% of the time and no more than 20 lbs.). Good
lighting and no special vision requirements, although employees may
spend significant amounts of time in front of a computer. Quiet
conditions. No exposure to outside, extreme weather, or hazardous
conditions. Additional Information
* Duties and responsibilities considered to be essential functions
of the position.
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Cantel is an Equal Employment Opportunity/Affirmative Employer.
Women, minorities, veterans, and individuals with disabilities as
well as other qualified individuals are encouraged to apply. All
qualified applicants will receive consideration for employment
without regard to race, color, religion, sex, sexual orientation,
gender identity or national origin or other protected class
Cantel maintains a drug-free workplace. Cantel is providing
notification that the unlawful manufacture, sale, distribution,
dispensation, possession, or use of a controlled substance or
marijuana is prohibited in the workplace and that violations will
result in disciplinary action up to and including termination.
Keywords: Regional Recreation Corporation of Wood Buffalo, Stratford , Sr. Quality Assurance Manager, Executive , Stratford, Connecticut
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