Cardinal Health-Gananoque manufactures many life impacting medical devices that help our customers thrive in a changing world. We are your humble partners, striving each day to make healthcare more efficient and effective and our patients as healthy as possible. We are more than 400 employees with 119 years of Canadian history, a deep understanding of the medical devices we manufacture every day and a passion for innovation. This is a senior level position that may serve in a leadership or mentoring role to one or more junior level Quality Engineers. The Senior Quality Engineer 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 Senior Quality Engineer 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. Working somewhat independently and under limited supervision, the Senior Quality Engineer will exercise judgment and complete objectives with minimal oversight. The position participates in the quality engineering functions within the manufacturing facility by assisting in developing, implementing and administering quality specifications, test methodologies, and sampling plans for product and process. This position works directly with Manufacturing, R&D and Engineering to assure quality considerations are adequately covered in the design, testing, and release of materials, components and completed products. Position is expected to provide quality-engineering expertise for the continuous improvement of product and process and provide engineering input for corrective and preventative action for in-house and customer reported problems. Participation in internal audits, supplier audits, and assessments by external parties is expected. Position is expected to function as a problem solver, capable of analysing problems and implementing root cause elimination solutions. Position maintains primary responsibility for critical quality systems including the internal audit program, CAPA system, and control of non-conforming product. This position is responsible for assuring overall regulatory compliance to the QSR and applicable Quality System standards. For more information on what it is like to work for us, please watch this video: Cardinal Health - Wings (https://www.youtube.com/watch?v=zA4HVn5g5DI) . **Responsibilities Include:** **1. Oversight of Quality Lab and Chemistry Lab:** + Manage QA Lead Hand, QA Lab Coordinator, and Chemistry Lab Coordinator + Manage and oversee all functions of the Quality Lab and Chemistry Lab with respect to incoming inspection, in-process monitoring, finished product release, chemical testing, and change control + Review/approve documentation changes that control incoming raw materials to ensure components and materials meet pre-established requirements prior to release for use in manufacturing + Ensure non-conforming material and components are communicated to appropriate personnel in a timely manner ​ **2. CAPA Program** + Manage CAPA program and follow up on actions and due dates. + Determine root cause/corrective and/or preventive actions + Mentor CAPA champion and team members **3** . **Complaints** + Perform customer complaint investigations + Determine root cause/corrective and/or preventive actions for customer complaints and externally generated customer SCARs **4. Non-conformance Program** + Manage non-conformance program + Facilitate and approve root cause/corrective and/or preventive actions for nonconforming material and/or material on hold + Facilitate MRB and recommend disposition of nonconforming product + Initiate and process Corporate holds and deviations + Initiate and process internal deviations **5. Process/Software Validations** + Provide input to validations + Review and approve protocols and completion reports ensuring quality requirements have been met **6. Six Sigma/Lean/Cost Savings Support** + Manage and/or participate in quality improvement projects including collaboration with R&D, Marketing, Regulatory, Stability Services, and Clinical Affairs + Support cost savings projects + Use of statistical tools to perform analysis and data trending + Perform process risk assessment and failure mode effects analysis (PFMEA) + Develop specifications and test methods to meet customer, product and internal quality requirements. This may include writing procedures to carry out requirements + Review new and modified product designs and processes for quality compliance **7. External Audits** + Participate in applicable Quality System Standards and Regulations, FDA, supplier, customer, and internal audits as required **8.** **New Product Development/Product Transfer/Process Transfer Support** + Represent the Quality function on NPD/Transfer projects + Provide quality engineering support for new product development **9.** **Continuous Improvement Initiatives** + Support Quality Improvement Teams + QA Improvement Training (SPC, Five-Why, FDA etc) + Maintain and evaluate sampling plans + Update/revise product control plans, inspection and test standards, and other site documentation where necessary + Document Change Request (DCR) reviews and approvals **10. Monthly Reporting for all Quality Metrics** **Desired Qualifications and Experience:** + College Diploma or Bachelor’s degree preferred and/or equivalent experience + 5-8 years in engineering or QA preferred. Medical device industry experience would be an asset + Previous experience in a supervisory role is preferred + FDA Regulated Industry experience as well as applicable Quality System Standards and Regulations is beneficial + Project Management, SPC, DOE, FMEA, sampling plans, statistics + Superior leadership, facilitation, and communication skills + Six Sigma Training/Lean Manufacturing Training + Good working knowledge of mechanical inspection techniques and equipment + Basic SPC skills and statistical sampling methods + Strong computer skills; Email, Word, Excel, PowerPoint, Minitab + Good working knowledge of Good Manufacturing Practices preferred + Internal and external auditing experience would be an asset + Experience in training, Train the Trainer certification beneficial **Our Employees all benefit from:** + Full dental and health benefits including life insurance from day 1 + Pension plan with employer matching level contribution + Incentive plan participation + Paid vacation days + Tuition reimbursement **_Cardinal Health is committed to employment equity and encourages applications from women, visible minorities, Aboriginal peoples and persons with disabilities._** **_Cardinal Health is committed to accommodating applicants with disabilities throughout the hiring process, in accordance with the Accessibility for Ontarians with Disabilities Act (AODA). Our Human Resources team is responsible for working with applicants requesting accommodation at any stage of the hiring process._** _Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply._ _Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. 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._ _To read and review this privacy notice click_ here (https://www.cardinalhealth.com/content/dam/corp/email/documents/corp/cardinal-health-online-application-privacy-policy.pdf)