Quality Engineer (Brantford, Canada)

at  Young Innovations

SITE OVERVIEW:

Germiphene knows infection control. Starting over 70 years ago, servicing the needs of the dental industry with our extensive product range; from disinfection, cleaning, instrument care, oral health, and hand care. Our drive for continued improvement is a daily commitment shown through new product development, strict quality standards and nurturing customer relationships. This has given us a strong foundation to grow our market to provide disinfection products, and hand sanitizers for all healthcare communities, and other government agencies.
We are innovators & manufacturers, we are professionals, we are educators, we are exporters, we are responsible, we are looking for like-minded individuals to join our team.

QUALIFICATIONS:

Education:

• A bachelors degree in engineering discipline such as Mechanical, Industrial, Manufacturing, Biomedical, Regulatory Affairs or other relevant field.

Skills/Abilities/Characteristics:

• Ability to analyze information , report research results, technical understanding, promote process improvement, develop standards, manage processes, manufacturing methods and procedures, supports innovation, CAD, Quality Engineering, shows willingness and aptitude to use own discretion in taking appropriate steps in finding solutions to problems; presents options and ideas to enhance current processes or procedures.
• Ability to maintain confidentiality. Ability to apply and adapt practices and techniques to the special requirements of senior management. Ability to establish and maintain effective relationships with other management staff, employees, and the general public. Demonstrates a systematic approach in carrying out assignments. Is very orderly and excels at cutting through confusion and turning chaos into order. Ability to present facts and recommendations effectively in oral and written form. Demonstrates a strong ability to identify, analyze and solve problems. Exhibits honesty, discretion, and sound judgment. Willing to work with others, collaborating and compromising where necessary; promptly share relevant information with others.
• Maintains a positive “can do” outlook, rebounds quickly from frustrations and unpleasantness, and maintains composure and friendly demeanor while dealing with stressful situations. Takes on additional responsibility when both big and small tasks need to be done. Ability to organize, prioritizes, and perform multiple tasks with minimal supervision.
• Excellent written and verbal communication skills. A sense of urgency, good attention to detail, and follow-thru. Unusually decisive in handling difficult problems. Translates problems into practical solutions. Excellent skills in Word, Excel, PowerPoint, Adobe Acrobat and Project Management - MS Project or SmartSheets preferred
• Strong chemical background
• Basic knowledge Product or Process Validations
• Basic knowledge of cGMP and regulatory requirements (medical device and/or drugs)
• Basic knowledge of dental products or medical devices
• Follow all safety and good housekeeping procedures to maintain safe working environment.

Experience:

• Successful track record of quality experience in manufacturing environment to include: Quality experience in HC, ISO 13485, applicable standards and regulations.
• 2-6years engineering experience required, preferably in the medical device industry. Product Development Engineering or Quality Engineering is acceptable, a mix is preferred.
• Experience in performing product and process validation, maintaining device master records, experience with engineering change orders, and experience creating statistical sampling plans.
• Beneficial experience including corrective action and preventative action (CAPA) or PPAPs, Lean manufacturing experience and experience training operators, preferred.

PHYSICAL REQUIREMENTS:

• Able to use a personal computer.
• Lift, carry, push and/or pull items
• Ability to exchange information via person, phone and email
  In compliance with AODA legislation, if you require accommodation during any part of the recruitment process, please advise Human Resources

ROLE OVERVIEW:

Under supervision of Director, Quality Assurance & Regulatory Affairs, the Quality Engineer will provide support to the manufacturing process within a team oriented, customer-driven organization. This position will provide quality engineering technical support to the facility related to corrective actions, process control, statistical analysis, component validation, product measurement and testing, product launch, product certification, and audits.

RESPONSIBILITIES:

• Perform product and process validation preparation and presentation (PPAP) and perform capability analysis
• Perform engineering change orders and product verification testing
• Provide frequent instruction, guidance and direction for manufacturing, engineering,materials, customers and suppliers in performance measurement
• Provide program launch support at the plant
• Support product development and production transfer to ensure process capability exists and product requirements are understood
• Utilize standard and advanced statistical analysis techniques to determine test sample sizes, protocol development, evaluate process capabilities, and develop statistically sound tolerance limits.
• Perform risk hazard assessments, dFMEA, pFMEA, and initiate action plans
• Support product development and production transfer to ensure process capability exists and product requirements are understood
• Support manufacturing/engineering problem solving efforts on in-process and vendor related problems.
• Use problem solving methodologies for in-process, supplier and customer quality issues
• Perform corrective and preventative actions
• Prepare for and host internal, customer and regulatory audits and internal system and process audits
• Investigate customer returns and complaints and provide corrective action / customer problem resolution; implement corrective action measures to prevent re-occurrence
• Use problem solving methodologies for in-process, supplier and customer quality issues
• Document Control
• Perform calibration of equipment/instruments
• Coordinate calibration from outside services
• Maintain Germiphene calibration program through the use of calibration management software program
• As member of Water System Team H2O, participle in weekly meeting for maintenance and troubleshooting
• Perform system daily check review and conductivity test
• Perform and coordinate all instruments calibration
• Complete risk analysis for products or processes with guidance from other department subject matter experts.
• Initiate and support change controls for new products and changes to formulation, specifications, testing, packaging and SOPs as required
• Author, co-ordinate execution and summarize IQ/OQ/PQ protocols for all applicable laboratory and production equipment
• Author, co-ordinate execution and summarize cleaning validation protocols
• Author, co-ordinate execution of proposed changes to validated production equipment or production processes
• Comply with GMP regulations, standard operating procedures, Good Laboratory Practices & Laboratory safety, and WHMIS.
• Will follow the responsibilities as outlined in the Ontario Health and Safety Act.
• Other duties as assigned