Supplier Quality Specialist- Ottawa
SUPPLIER QUALITY SPECIALIST – DNA Genotek Inc., Ottawa
The focus of this position is to strengthen DNA Genotek’s supplier management process (including design transfer, incoming inspection, supplier feedback and supplier audits) work with suppliers to resolve issues that arise, and assist them in taking corrective / preventive actions to prevent recurrence of non-conformances. The scope of this position includes quality management of suppliers of components, suppliers of services and contract manufacturers.
RESPONSIBILITIES / DELIVERABLES:
- Manage projects to resolve supplier quality issues, improve supplier quality, and act as a technical contributor to those projects.
- Qualify new suppliers or second sources for existing suppliers.
- Continuously improve processes and procedures for design transfer, incoming inspection, supplier evaluation and supplier feedback.
- Perform supplier evaluations, on-site supplier audits and monitor improvement plans.
- Monitor supplier quality, create and track SCARs when nonconformances occur.
- As a key member of the Quality team, contribute to continuous improvement of all aspects of the quality system.
- As a primary Quality Assurance interface with suppliers, occasional meetings at odd hours and travel will be expected.
- Support the configuration management processes between DNAG and its suppliers, including its single order fulfilment contract manufacturers.
- Support new product introduction, including risk management, design review, FMEAs, design transfer, quality planning, determining incoming inspection requirements and first article procedures for new components, etc.
- Perform complaint investigations related to assigned supplier(s).
- Any other duties deemed appropriate for a Quality Engineer.
- Degree in a science or engineering discipline, or an equivalent combination of relevant job experience, training and knowledge.
- Recognized Quality Management System training or certifications such as Certified Quality Engineer, Certified Supplier Quality Engineer.
- ISO 9001 / 13485 auditor certification is an asset.
EXPERIENCE and QUALIFICATIONS:
- Minimum 5 years experience in a role that included resolving challenging technical problems with suppliers, preferably in the medical device or similarly regulated industry.
- Experience building productive, collaborative relationships with suppliers.
- Good understanding of quality systems and supply chain management.
- Familiar with probability, statistical methods in general and acceptance sampling plans in particular.
- Demonstrated strong analytical ability and technical judgment.
- The ability to prioritize tasks in a busy work environment, be customer-focused and detail oriented.
- Excellent written and oral communication skills in English.
- Familiarity with ISO 9001, ISO 13485 and medical device GMP regulations.
- Proficiency in MS Office Applications.
- Able and willing to travel to supplier or customer sites, including internationally.
This position requires the submission of both a resume and cover letter.
In your cover letter, please include:
- Name and contact details
- A list of how your qualifications match our requirements as listed above
- A summary of why you’re right for the job
At DNA Genotek, we are committed to building and preserving an accessible, welcoming, supportive, fair, and inclusive environment.
Accommodations are available to support prospective employees during the recruitment and hiring process. Should you require any accommodations, please advise us in advance so that we can work with you to find a suitable accommodation.
SEND COVER LETTER & RESUME TO:
Quality Manager, DNA Genotek
3000-500 Palladium Drive,
Ottawa. ON. Canada K2V 1C2
Toll Free: 1-866-813-6354