Sr. Quality Assurance Manager

Company: Regional Recreation Corporation of Wood Buffalo
Location: Stratford
Posted on: February 23, 2021

Job Description:

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 methods. *
• Oversee local calibration system and ensure all instruments, materials, written procedures, etc., used in inspection process are current.
• 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 requirements.
• 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 facility.
• Support Corrective and Preventive Action (CAPA) System
• Support supplier quality audits and serve as Internal Audit Team member
• 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' manufacturing environments.
• 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 techniques.
  • 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 projects
  • Demonstrates skill at managing by influence and completing tasks through others in non-reporting relationships.
  • Good presentation and training skills for both internal and external audiences
  • 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 Demands
    • 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.
      **EEO/Affirmative Action Employer Sorry the Share function is not working properly at this moment. Please refresh the page and try again later. Share on your newsfeed Loading...
      
      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 status.
      
      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