Start : Immediate
Duration : Permanent, full time
Founded to empower every medical professional with accurate, easy to use and affordable imaging tools. We're miniaturizing high quality point-of-care ultrasound to offer a safe and cost-effective option for all clinicians in every specialty
Work with the QA team, Purchasing, Manufacturing Engineering, Research & Development, Customer Support, and external suppliers to ensure product and material performance is adequately monitored and where problems occur, appropriate and timely root cause analysis and corrective actions are implemented as required.
Develop inspection documents for First Article Inspection, incoming parts / materials, product in process, and outgoing product.
Disposition and trend of non-conforming parts and product. Champion problem solving and root cause analysis activities with internal and external suppliers and customers to eliminate recurrence of non-conformances.
Monitor, communicate, and improve key supplier performance criteria such as KPI's and CTQ's, including Supplier OTD (Past due), DPPM and scrap.
Including supporting supplier's SCAR management.
Address in-process quality issues in a timely manner to ensure continuity of production and supply. Engage QA, Purchasing, Production, R&D, and as required.
Work with Purchasing and Production to evaluate and approve new suppliers and / or processes as part of the New Product Introduction process
Track supplier performance to increase supplier capability.
Support CAPA process.
Assure compliance to all applicable regulatory and legal requirements pertaining to the QMS; including ISO 13485, FDA 21 CFR Part 820 and ISO 14971
Participate in product realization process (including FMEA)
Support deviation, DCO, ECO approval.
Perform internal and external quality audits.
Assist in the maintenance and improvement of the QMS through the review and creation of procedures and work instructions.
3 - 5 years' experience in a Quality Assurance environment. Hands-on working experience with ISO 13485, FDA 21 CFR Part 820 and ISO14971 (or similar regulated industry standards)
Experience in a regulated industry is a requirement.
Work authorization for Canada
Post-secondary technical degree (mechanical or electrical / electronic preferred).
Certified internal or Lead auditor in ISO13485, FDA 21CFR Part 820 and / or ISO14971 is a plus. Hands-on experience in conducting both internal and external audit.
Apply today for immediate consideration or contact Aaron O'Byrne for further information.
Candidates must be legally entitled to work in location advertised.
Annex Consulting Group is a full-service IT and management consulting firm, specializing in staff augmentation contracting, permanent staffing, and outsourced solutions.
Not interested but know someone who is a fit for this role? Check out the award-winning Annex Referral Program .
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