Supplier Quality Engineer

Company: TeDan Surgical Innovations
Location: Sugar Land
Posted on: May 12, 2022

Job Description:

Company description: TeDan Surgical Innovations (TSI) designs and manufactures specialty surgical products for use in orthopedic, neuro, thoracic and spine surgeries. TSI was founded in 2006 with the goal to innovate and address evolving retraction techniques in spine surgery. We have successfully addressed the need for minimally invasive, posterior, lateral and anterior surgical approaches to the spine, and have introduced access instrumentation for neurological, orthopedic and cardiothoracic procedures. We commit to providing innovative, high-quality surgical access systems designed to optimize exposure and improve the surgeon experience. Job Summary: The Supplier Quality Engineer (SQE) will be responsible for providing Quality Engineering support and leadership for day-to-day operations of Supplier Management and activities relating maintaining Approved Supplier List, supplier selection, evaluation, and performance. This position partners closely with subject matter experts to identify, investigate and resolve product non-conformances while supporting continuous improvement initiatives. The position requires continuous on-site support to internal stakeholders such as RAQA, Operations and Purchasing. Duties/Essential Job Functions: Manage supplier quality performance to achieve organizational quality objectives. Own and report supplier quality issues. Maintain the Approved Supplier List (ASL) through review and approval of new supplier requests, change requests, and supplier selection plans. Develop, implement, and maintain appropriate metrics to assess supplier performance. Initiate and manage supplier corrective action requests (SCARs) to ensure effective problem resolution by suppliers. Trend, investigate, and ensure completion of supplier non-conformances. Partner with Operations, through communications with suppliers, regarding Quality Control issues with processes and/or products. Develop and maintain supplier audit schedule.; perform supplier audits as required. Drive root cause analysis of product quality issues and implement solutions to resolve the issues; assist other personnel, as required, with the Corrective Action process for purchased product and/or services. Support TSI audit team during audits (i.e. FDA, Notified Body, Customer, Supplier, Internal). Generate and maintain responsibility for Supplier Quality Agreements that align with TSI expectations for the manufacture of TSI products to ensure compliance with current standards, guidance documents, and regulations for the sale of product in the US and OUS as applicable. Maintain up-to-date documentation for supplier files, including but not limited to: quality standards/regulatory certifications, regulatory information (including FDA registration information, UDI information, GMDN codes, etc.), standards operating procedures, quality manual, manufacturing flow charts, process validations, and identification of all sites, including sub-contractors, where manufacturing activities are performed. Other responsibilities assigned by supervisor include, but not limited to: vendor site audits, general corporate functions associated with role as Quality Engineering professional. Knowledge/Skills/Experience: 5 years--- experience within regulated medical device / pharmaceutical industry in as Supplier Quality Engineer (SQE) Demonstrated knowledge of FDA regulations, ISO 9001, ISO 13485, CMDR, Medical Device Directive Regulation (93/42EEC), EU MDR 2017/745, and other National and International regulations and standards Demonstrated ability to manage, plan, organize and implement multiple concurrent and competing priorities in a fast-paced environment Excellent independent problem-solving, organizational, analytical and critical thinking skills with the ability to handle multiple tasks in a fast-paced environment Understanding and implementation of statistical techniques Strong technical writing skills and ability to create technical reports as well as manufacturing / inspection procedures with strict attention to detail Experience with change control, CAPA and deviation quality systems High level of computer skills Communication: Ability to internally and externally discuss and clearly define key technical and process issues and independently develop course of actions/plan Business Acumen: Require a basic understanding of business and financial impact of product Teamwork: Must be able to work in a team environment. Pursue trust for each team member. Seek and deliver honest feedback to all team members. Committed and accountable to achieving team goals. Abide by team decisions. Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) Required Education: Bachelor of Science (B.S.) degree in Biomedical, Mechanical or Materials Engineering with experience in the medical device industry Physical Requirements: Business casual attire. Occasionally requires attending corporate functions. Occasionally may require travel (5-10%) Job Type: Full-time Benefits: 401(k) Dental insurance Flexible spending account Health insurance Life insurance Paid time off Parental leave Tuition reimbursement Vision insurance Schedule: Monday to Friday

Keywords: TeDan Surgical Innovations, Sugar Land , Supplier Quality Engineer, Engineering , Sugar Land, Texas