Quality Engineer
Gananoque (Leeds and Grenville United Counties) Bachelor's Degree Design / Civil engineering / Industrial engineering
Job description
SUMMARY OF POSITION:
This 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 analyzing 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.
ESSENTIAL FUNCTIONS:
Responsible for seeing that all tasks are performed in a manner that complies with Covidien and Ludlow Technical Products Canada Ltd. policies.
1. Support Quality Assurance System
– Manage internal audit program including conducting quality audits.
– Develop subsequent corrective/preventive actions for internal audits.
– Perform calibrations and write procedures as required.
– Documentation as required.
– QA system training.
– Metrics reporting.
– Knowledge of applicable regulatory standards.
2. Process/Software Validations
– Perform validation studies as required.
– Provide input to validations.
3. CAPA Program
– Manage CAPA program and follow up on CAPA actions and due dates.
– Determine root cause/corrective and/or preventive actions for CAPAs.
– Mentor CAPA champion and team members.
– Reporting.
4. Supplier Development
– Monitor supplier performance.
– Manage SCAR program, initiate SCARs, and track SCAR corrective actions and due dates.
– Perform supplier audits and initiate/monitor follow up actions as required.
5. Customer Complaint Handling
– Perform customer complaint investigations.
– Determine root cause/corrective and/or preventive action for customer complaints and externally generated customer SCARs.
6. Nonconformance Program
– Manage nonconformance 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.
7. Six Sigma/Lean/Cost Savings Support
– Manage and/or participate on 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.
8. External Audits
– Participate in applicable Quality System Standards and Regulations, FDA, supplier, customer, and internal audits as required.
9. New Product Development/Product Transfer/Process Transfer Support
– Represent the Quality function on NPD/Transfer projects.
– Provide quality engineering support for new product development.
10. Production Floor Support/Continuous Improvement Initiatives
– Support focus factory core teams.
– Support resolution of production floor issues including aiding in problem solving.
– Support Quality Improvement Teams (lead and participate).
– QA Improvement Training (SPC, Five-Why, FDA etc).
– Support SPC program in assigned focus factory areas.
– 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.
11. Facility Sterilization/Environmental Monitoring
– Where applicable, monitor and maintain sterilization programs for products, including pre-sterilization and post-sterilization procedures, documentation, review of results and release to inventory.
– Monitor bioburden and dose audits for sterile product.
– Perform particulate monitoring for controlled manufacturing environments.
12. QA Technician Personnel
– Manage QA Technician direct reports.
– Provide career development and mentoring.
– Enact disciplinary measures as required.
– Perform annual performance reviews.
– Conduct interviews for new hires.
13. Provide Assistance to QA Manager
– Act as back up for QA Manager when required.
DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
Other duties as assigned with or without accommodation.
WORKING CONDITIONS:
This position requires exposure to office conditions as well as in a manufacturing area with machinery and equipment in close proximity.
DISCLAIMER:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
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Desired profile
MINIMUM REQUIREMENTS :
Education:
Bachelor’s degree preferred and/or equivalent experience.
Experience:
1-3 years in engineering or QA preferred. MDD and CMDR experience preferred.
Preferred Skills/Qualifications:
FDA Regulated Industry experience as well as applicable Quality System Standards and Regulations experience...
Skills/Competencies:
Project Management, SPC, DOE, FMEA
Other Skills:
Six Sigma Training/Lean Manufacturing Training
The physical demands described here are representative of those that must be met by an associate to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Amount of Time
None <1/3 1/3 to 2/3 >2/3
(Never) (Occasional) (Frequent) (Regular)
Stand X
Walk X
Sit X
Use Hand to Finger, Handle or Feel X
Reach with Hands and Arms X
Climb or Balance X
Stoop, Kneel, Crouch or Crawl X
Talk or Hear X
Taste or Smell X
Lift up to 10 lbs. X
Lift up to 25 lbs. X