The Quality Engineer (QE) will have responsibility for field product quality and will provide support to the Rakuten Aspyrian Supply Chain Team, Clinical Operations and field personnel in the areas of product assurance and reliability. The QE will coordinate activities with outside vendors, manufacturing sites, distribution centres and field personnel in the performance of failure analysis of components used in implantable grade medical devices including needles, obturators, fibre optics and packaging/labelling of laser light systems and ancillary products.
The QE will provide input on supplier issues and recommend changes for improvements to operating efficiency. The QE will provide support in areas of product quality engineering to drive continuous improvements and work with supply chain team members to ensure highest product quality and assure compliance to internal procedures and applicable external standards and regulations. As a key member of the quality team, the QE will participate in the Rakuten Aspyrian Quality Management System (QMS) to support the manufacture and distribution of medical combination drug/devices and for expanding the system as products progress through development to commercialization. This individual will also be responsible for processing and trending of field quality complaints for clinical and marketed combination devices. The individual will also have a key role in working with outside vendors and participating in GxP quality audits and maintaining quality documents between Rakuten Aspyrian and vendors.
This position is a key member of the Rakuten Aspyrian Quality team. The individual will participate in the logistical planning of quality support for therapeutic laser devices, concomitant drug product and ancillary products. The position will participate in the oversight and maintenance of all controlled documents, procedures, reports, files, training records and scanned files.
Key Duties and Responsibilities
- Develops, modifies, applies and maintains quality standards and specifications for processing materials into partially finished or finished materials product.
- Devises and implements methods and procedures for inspecting, testing and evaluating product components, materials, packaging or processing methods.
- Conducts quality assurance analysis of tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
- Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
- Supports implementing containment and mitigation actions while driving timely disposition of non-conforming product
- Conducts root-cause analysis using defined methodologies including identifying appropriate corrective and preventive actions and establishing effectiveness plans.
- Supports production and process change control through review and approval of documentation, ensuring adequacy of verification or validation to support the change, good documentation practices and compliance to procedures.
- Generates, reviews and approves quality system documents including manufacturing process updates, non-conformance related documentation, process and equipment qualifications, and change orders
- Supports vendor assessment of methods or equipment for impact on manufacturing processes, product, and compliance to requirements.
- Reviews and analyses quality trends with the Supply Chain team and recommends actions for process, equipment and system improvement
- Coordinates with customer facilities and internal engineering resources to respond to customer facility questions and resolve complaints.
- Participates in audit/assessment of manufacturing operations and recommends corrective/preventive actions and process improvements.
- Communicates significant issues or developments identified during quality activities and participates in process improvements to instil rigor in processes and product.
- Facilitating GxP documentation approval between Rakuten Aspyrian and outside vendors as well as internal customers to include assistance with MSAs, NDAs and Technical Quality Agreements
- Participate in the change control process and/or assist with the review of documents to include product history files and batch records
- Participating in the vendor qualification and oversight program in support of product Supply Chain needs
- Provide product or vendor performance data for Management Review and work with various departments to draft appropriate metrics reports
- Reviewing and approving documents from vendors against internal source documents, including batch records, specifications, stability information, and analytical methods/qualifications
Desired Education, Skills and Experience
- Bachelor’s degree in manufacturing engineering, Mechanical or Electrical Engineering or similar branch of education preferred
- CQE or Six-Sigma certification preferred
- Minimum 5 years of experience in quality control of medical devices, IVDs or combination products
- Excellent organizational skills and ability to meet deadlines
- Ability to travel for purposes of training and vendor management
- Collaborative and interpersonal skills to work in a team environment both internally and with outside vendors or clients
- Ability to work in a fast-paced, rapidly changing environment
- Working knowledge with Word, Excel, Adobe and formatting documents.
- Experience with Electronic Quality/Document Management Systems required
Location: San Mateo, CA
Type: Full-time: Full Time
Experience: Some Experience