Description
- 3-5 years of total industry experience with 4+ years of related experience in a medical device or regulated industry.
Description:
- Strong project leader with effective communication skills, organization and ability to multi-task
- Working knowledge of appropriate global medical device regulations, requirements and standards such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO14971, European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, and ISO 9001.
- Familiar with Quality tools such as: Six-Sigma, 8-D, CAPA, FMEA, 5WHY, etc.
- Experience in root cause analysis, corrective and preventive action methods.
- Implement Quality Engineering, Purchasing Controls and Supplier Quality processes related to the development, procurement and continuous improvement of manufacturing materials, components, software, sub-assemblies, contract manufactured finished devices/products or services, and their introduction into supply chain. Ensure compliance to regulatory requirements and/or procedures for regulated products/processes. Ensure raw material and component specs and drawings are translated to supplier quality requirements, qualify suppliers, assess metrics of whether supplier products meet quality specifications, and audit suppliers critical to quality processes. Ensure that validations are completed where specified, and control plans exist to ensure the sustained quality and compliance of supplied raw materials and components. Ensure correction and prevention activities of suppliers are timely and effective.
- Partner with R&D, Operations and Procurement personnel to proactively engineer quality and ensure compliance for raw materials, components, finished products etc., from suppliers
- Develop and support regulatory compliance gaps at suppliers, including supplier quality system and process development activities
- Manage additions/deletions/changes to the status of suppliers on the Approved Supplier List, including supplier master file records
- Ensure raw materials/components/products at supplier(s) are released from supplier(s) to according to the agreed requirements
- Perform 3rd party product compatibility risk assessments in partnership with R&D and Market Procurement (Markets SQE)
- Drive quality and compliance development and/or improvement at suppliers when needed; face to supplier(s) on lean improvements
- Knowledge and experience with Special Process Validation
Education:
- Bachelor's degree in an engineering or science discipline, or equivalent experience.
- Current certification with a recognized Accreditation body (ie, RAB-QSA/IRCA) or successful completion of ASQ certification as a Certified Quality Engineer (CQE) and Certified Quality Auditor (CQA) or Certified Biomedical Auditor or successful completion of a recognized Lead Auditor course.