Quality Assurance Manager in Morrisburg, Ontario at KaVo Kerr

Date Posted: 6/19/2019

Job Snapshot

Job Description

Job ID: KAV003995

About Us

KaVo Kerr is a cohesive organization comprised of two global leaders, united to provide dental excellence and serve as a single premier partner for the dental community.  KaVo Kerr operates with a common vision inspiring and helping our customers, their patients and our own associates realize their potential.  KaVo Kerr offers solutions for endodontics, restoratives, treatment units, infection prevention, imaging, rotary and instruments.


Description

JOB SUMMARY:


The Quality Assurance Manager supports the Morrisburg site with a strong focus on Quality Compliance, Quality Control and Quality Operations. The main responsibilities for the position’s team are Final Product Acceptance, product identification and segregation, support internal and external audits, nonconformance’s, MRB, CAPA’s, complaint handling, document control, calibration, Quality system improvements, and manage the Quality Control staff to support production operations. This position also is the Quality Management Representative as defined by the Code of Federal Regulations Title 21 Section 820.20 (3) and ISO 13485:2016 Section 5.5.2.


ESSENTIAL DUTIES & RESPONSIBILITIES:

  • Support Production Operations by ensuring compliance in Production documentation (GDP, work orders, NCR’s, product segregation identification)
  • Responsible for the site’s Quality Management Systems including:  Document Control, Complaint Handling and CAPA.
  • Ensure Quality Compliance throughout entire Manufacturing (GDP, Work
  • Order documentation completion and compliance, non-conformance compliance to applicable ISO 13485 standards).
  • Ensure adequate incoming inspections test methods and calibrations.
  • Ensure site compliance with calibrations and maintain calibration system and records
  • Identify and correct potential compliance issues (handling of variances, material segregation and identification, training for site both Quality and Manufacturing).
  • Ensure site training and site compliance lead for audits.
  • Manage product under quarantine between sites.
  • Support MRB and final product dispositions.
  • NCR and variance support and trend reporting.
  • Manage Quality Control staff to support operation.
  • May require 5-10% travel as needed. 


Job Requirements



Qualifications

REQUIREMENTS:

 

  • BS degree required (in Science or Engineering preferred) or equivalent education and/or combination of relevant experience.
  • 2-4 years of Quality Management experience, preferably in a Class I medical device environment.
  • Possess working knowledge of 21 CFR820, ISO13485, ISO14971 and other applicable FDA and ISO regulations and laws.
  • 2-4 years prior supervisory or people management experience required.

QUALIFICATIONS:

  • CQM/OE, CQE, or CQA preferred.

  •  Proficiency in standard office tools, including Excel, Access, Word and Power Point.

  •  Strong oral, written communication and teamwork skills.

  •  Dynamic Leader with strong problem solving skills.

  •  Ability to motivate and lead a diverse team to achieve productivity targets.

  • Ability to make rational, objective & appropriate decisions relating to company & department needs.

  • Ability to identify customer needs & issues & develop realistic solutions to meet needs & solve problems.

  • Ability to communicate decisions across the organization.

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available at: http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf.


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Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.

At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.

Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.