Quality Assurance & Engineering Manager

by Trudell Medical International

Position Type: Full-time
Location: London, ON
Date Posted: Nov 06, 2021
Trudell Medical International

Job Description


Quality Assurance & Engineering Manager

 
As a leader in our Quality Assurance team, you will drive TMI’s continuous improvement and quality culture with internal Quality teams, Operations teams and suppliers. Manage day to day quality related activities within TMI, including supplier support, in collaboration and in support of other departments as required.
 
RESPONSIBILITIES INCLUDE:
PEOPLE MANAGEMENT AND DEPARMENTAL ADMINISTRATION
  • Provide staff with clear goals, objectives, and expectations.  Coach them to succeed.
  • Establish and monitor schedules and time standards, i.e., by organizing and directly supervising staff, administering leave, monitoring, and responding to staff headcount requirements, etc. 
  • Treat employees fairly and equitably.  Consistent application of workplace policies and programs
  • Encourage employee personal and professional development, i.e., by evaluating performance, providing feedback, and supporting growth
  • Resolve employee relations issues, performance problems, and disciplinary issues ensuring employees are not distracted from focusing on outcomes
  • Provide input for the budget process and work within approved department budget
 
QMS MANAGEMENT
 
  • Manage the QMS and ensure maintained compliance to ISO 13485.
  • Implement policies, systems, procedures and practices to ensure that quality, configuration and reliability requirements are established and followed
  • Direct quality assurance activities towards process improvement, continuous quality improvement, cost effectiveness of processes, systems and procedures and positive preventative and corrective action
  • Manage an internal quality audit program ensuring the necessary scrutiny of the quality system components according to a published and approved schedule, and to ensure that the operations of all functional groups comply with established standards
 
PLANNING AND VENDOR MANAGEMENT
  • Assist in the review and approval of vendors from a quality perspective, and provide input into vendor selection and vendor evaluation/rating
 
INSPECTION AND NONCONFORMANCE RESOLUTION
  • Organize and manage in-coming and in-process inspection and release of finished goods for shipment.
  • Revise and document current best inspection practices
  • Manage the Non-Conforming Report and Temporary Deviation processes
 
NEW PRODUCT DEVELOPMENT SUPPORT
  • Deploy appropriate resources to development projects.
  • Support development activities per agreed upon timeframe
 
HEALTH AND SAFETY AND POLICY COMPLIANCE
  • Comply with relevant health and safety legislation, including the Workplace Safety and Insurance Act, the Occupational Health and Safety Act, etc.
  • Responsible for employee health and safety, i.e. by maintaining personal competency in departmental processes, equipment operation, materials usage etc., understanding associated hazards in the department, and protecting workers from those hazards through information, training, and enforcement of procedures, laws, etc.
  • Maintain equipment and facilities in safe condition, i.e. by maintaining personal competency in what “safe condition” looks like, conducting regular inspections, and addressing hazards if they arise
  • Manage employee awareness and compliance with TMI’s Disability Management Procedure, i.e., by maintaining personal competency in the Procedure, informing employees of it, and enforcing it
 
QUALIFICATIONS:
  • Degree or Diploma in Manufacturing Technology, Engineering or a related field of study
  • Accreditation from within the quality discipline in the fields of auditing, quality engineering, or quality management; equivalent experience may be considered
  • Lead Auditor or Internal Auditor training is an asset
  • 5 years of experience in quality management systems (QMS). Experience in QMS compliant to ISO13485 standard is preferred.
  • 3 years of people leadership / management experience
  • Strong knowledge of ISO9001 or ISO13485
  • Familiarity with domestic and international standards appropriate for medical devices
  • Experience with cGMPs (21 CFR part 820)
  • Experience in conducting review audits
  • Experience with GLPs is an asset
  • Good written and oral communication skills
  • Good interpersonal and organizational ability
  • Good working knowledge of statistical methods
  • Working knowledge of metrology
  • Computer literate with intermediate to advanced experience in MS Office applications

 
If you interested in this employment opportunity, please apply through LinkedIn
 

 
At the applicant's request, TMI will make accommodation to its recruitment process to meet the needs of applicants with disabilities.
Please send your résumé only once per position.
Résumés will be accepted throughout the process, but only candidates selected for interviews will be contacted.
TMI is an equal opportunity employer.
We thank all applicants in advance for their interest in joining our team.


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