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Vacancy: Quality Manager, Gananoque, ON, Canada

Vacancy: Quality Manager, Gananoque, ON, Canada

How to apply

Job Number: 20085705
Location: Gananoque, ON
Country: Canada
Date Posted: 8/5/2021
Type:Full time
Employment Type:Regular

Cardinal Health Canada, with over 1300 employees nationwide, is an essential link in the Canadian healthcare supply chain, providing over 70,000 products to healthcare facilities and medical professionals across the country. Cardinal Health-Gananoque manufactures many life impacting medical devices that help our customers thrive in a changing world. We are more than 450 employees with 119 years of Canadian history, a deep understanding of the medical devices we manufacture every day and a passion for innovation.

We are currently seeking a Quality Manager to add to our Gananoque, ON facility. Under the general direction of the Director of Quality, this position is responsible for the development and implementation of quality programs in their respective areas of responsibility for inspection and testing, auditing, training and other related quality functions.

This is a leadership position that serves as a coaching and mentoring role to the Quality Team and the facility with respect to Quality. The Quality Manager will have a strong in-depth knowledge and complete understanding of standards, principles, and techniques utilized within the Quality Assurance field. With full knowledge of industry practices, the Manager will anticipate problems, develop solutions, and make decisions necessary to solve those problems. The solutions may require integration of multiple factors and often require collaboration, thoroughness and accuracy consistent with department/plant objectives. The QA Manager participates in the quality engineering functions within the manufacturing facility by assisting in developing, implementing and approving quality specifications, test methodologies, and sampling plans for product and process. This position works directly with Marketing, Product Managers, Sales, Regulatory, Manufacturing, R&D and Engineering to assure quality considerations are adequately covered in the design, testing, and release of materials, components and completed products. The Quality Managers is responsible for creating, developing, maintaining an effective Quality Management System that aligns with corporate procedures and all applicable standards and regulations.

Your Contributions to the Organization will be to:

-Manage Quality budget; allocate resources, tools and equipment as required for the department.
-Manage Change Control for site; support cost savings and continuous improvement initiatives throughout the facility.
-Hold Management Review meetings as scheduled and following up on improvement actions.
-Manage the facility's Internal and Supplier Audit program and participate in ISO, FDA, corporate and customer audits as required.
-Support process validation and calibration programs and activities for the facility.
-Manage the non-conformance program for the facility. Support non-conformance closure for product and material on hold, facilitating Material Review Boards to determine disposition of nonconforming products.
-Manage Customer Complaints program. Investigate and respond to customer complaints, including facilitating Material Review Boards to determine disposition of nonconforming product.
-Manage and maintain facility CAPA program and support continuous improvement initiatives.
-In conjunction with R&D, Operations and Sales and Marketing, develop specifications and test methods to meet customer, product and internal quality requirements.
-Implement and maintain sterilization programs for products, including pre-sterilization and post-sterilization procedures, documentation, review of results and release to inventory.
-Implement and maintain Supplier Performance as it relates to product quality, Supplier Corrective Action and Calibration systems; conduct Supplier Audits; coach and train new auditors.
-Manage and maintain the Quality Document Control System for the facility. Manage Artwork files for facility, manage labelling database for all products, including creation in label software and GTIN’s for all finished goods.
-Conduct communication of quality internally and externally on a daily, weekly, monthly, and quarterly basis.
-Support training requirements for facility, conduct quality orientation, defect training and product awareness. Support training software that houses all electronic training and maintain skills matrices for facility.
-Managing and overseeing all incoming raw material receiving and inspection activities as well as finished product release requirements.
-Ensure quality record retention requirements are maintained and controlled as outlined in quality procedures.

This Job might be for you if you have:

-Bachelor’s degree preferred and/or equivalent experience
-5-8 years in engineering or QA preferred. MDD and CMDR experience preferred.
-FDA Regulated Industry experience as well as applicable Quality System Standards and Regulations experience.
-Project Management, SPC, DOE, FMEA, sampling plans, statistics is a benefit.
-Superior leadership, facilitation, and communication skills.
-Presentation Skills: Be able to train and or present quality information to facility, outside contacts.
-Six Sigma Training/Lean Manufacturing Training is an asset.
-Good working knowledge of mechanical inspection techniques and equipment
-Basic SPC skills and statistical sampling methods
-Strong computer skills; experience with MS Word, MS Excel, MS PowerPoint, Minitab
-Good working knowledge of all products manufactured including product development, complaint processing, raw materials verifications, sterile products procedures
-Certified Internal Auditor
-Strong communication skills
-Experience in training; Train the Trainer certification

Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.


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