Careers

Careers

Join the team committed to revolutionizing cancer treatment

Job Summary

This role is responsible for supporting Quality Engineering activities related to establishment and implementation of incoming, in-process and finished product testing and inspection; performance and documentation of failure investigations; and measuring and reporting on the health and performance of the quality management system. This role also supports Quality System activities associated with establishing and implementing a 13485:2016 compliant quality management system, including use of Arena PLM for parts management and quality processes, procedure writing, process mapping, and process improvement efforts.

Job Location

California, USA

Essential Duties and Responsibilities:

  • Lead the Material Review Board (MRB) to investigate and disposition nonconforming materials.
  • Investigate and document Nonconformance Reports (NCR) and Corrective and Preventive Actions (CAPA).
  • Establish Quality Inspection Plans (QIPs) for in-process assembly and finished product assembly and installation testing and inspection based on understanding of Critical to Quality attributes (CtQs).
  • Implement efficient and actionable metrics measurements (Quality Indices) throughout the quality management system.
  • Support the establishment of clearly specified sub-assemblies, assemblies and BOMs through Arena PLM Item
  • Master creation and improvement.
  • Support activities related to Design Controls and Risk Management as needed.
  • Support generation of weekly Quality Indices metrics reports.
  • Lead and support performance of supplier quality audits, domestic and international.
  • Serve as Person Responsible for Ownership (PRO) for the quality system elements of Monitoring, Measurement, Analysis & Improvement; Control of Nonconforming Product; Corrective and Preventive Action, and Statistical Controls.
  • Comply with written requirements, recommending improvements and enhancements to processes, and performing other duties assigned by leadership.

Job Requirements:

  • Bachelor's degree (BS) in technical or life science field.
  • 3 years’ experience in a medical device or pharma/biotech quality system (i.e., ISO 13485, ISO 14971, 21 CFR Part 820, 21 CFR Part 11)
  • Strong writing skills related to authoring and editing procedures, plans, reports, investigations, protocols, and other quality system documents.
  • Strong analytical and problem-solving skills, demonstrating sound judgment and understanding of strategic context.
  • Experience participating in cross-functional teams to successful outcomes in support of business priorities is preferred.
  • Experience using MS Office Suite.
  • ASQ Certified Quality Auditor, Biomedical Auditor, and/or Quality Engineer preferred.
  • ISO 13485:2016 Lead Auditor certification preferred.
  • Results-oriented, positive “can-do” attitude with demonstration of appropriate urgency and initiative.
  • 10-20% domestic and international travel may be required

Job Summary

TAE Life Sciences (www.taelifesciences.com) is seeking a technical service engineer with strong background in engineering or physics and solid experience in installation, service, or technical project management of large-scale complex capital equipment. This individual would support radiotherapy device development effort, and will act as a TAE Life Sciences representative in China, coordinating installation and servicing of medical accelerators, working with partners and vendors, and facilitating the business of TAE Life Sciences in China. 

Job Location

Xiamen, China 

Job Description

1) Coordinate activities of TAE Life Sciences in China, including installation and maintenance of medical accelerators, managing vendors, and overseeing technical operations.
2) Facilitate the interaction and ensure tight integration with and efficient knowledge transfer between TAE Life Sciences and its partners and collaborators.
3) Write detailed procedures and reports to support the installation and operation of TAE Life Sciences medical accelerators.
4) Ensure a solid long-term working relationship between TAE Life Sciences and its partners in China based on integrity, trust, and professionalism, securing future business opportunities.

Education:

Required: BS in engineering, physics or related discipline + 7 yrs. experience. Advanced degree preferred.

Required Job Knowledge, Skills and Abilities:

1) Minimum 3 years of experience in capital equipment installation and servicing, or managing complex experimental projects
2) Proficiency in English and Chinese
3) Excellent verbal and written communication skills
4) Strong experience in at least one of the following areas:
* Mechanical engineering
* Electrical engineering
* Electronics
* Particle accelerators
* Radiotherapy devices
* Vacuum systems
* Industrial control systems
* Supply chain management
* Manufacturing

5) Strong technical knowledge and aptitude to quickly understand systems and technical concepts.
6) Proven decision-making skills and ability to effectively manage multiple priorities.
7) Ability to work independently with little or no supervision while maintaining a high level of efficiency.
8) Ability to thrive in a challenging, dynamic environment. Must be flexible and quick to adapt to sudden changes and issues.
9) Outstanding analytical and troubleshooting skills. Able to resolve conflict and drive issues to resolution.
10) Detail oriented and organized with a strong discipline of adhering to standards.
11) Ability to cooperate and communicate well with engineering, physics/science, project management and procurement groups.

 

 

TLS is in search of a Procurement Specialist or Senior Procurement Specialist with expertise in quoting, sourcing, and procurement processes.

Essential Duties and Responsibilities:

General Procurement Tasks

  • Purchase goods, materials, components, and services.
  • Obtain quotations for products and services.
  • Negotiate terms with suppliers, such as price, quality of goods, deadlines, and expectations.
  • Prepare and place purchase orders in NetSuite.
  • Maintain purchasing files.
  • Work with AP to resolve invoice discrepancies, define payment terms, and set up new suppliers in NetSuite.
  • Coordinate and execute engineering-change-order (ECO) activities with suppliers, the quality team and the engineering team.
  • Comply with quality standards and regulation, including FDA 21 CFR 820 and ISO 13485.

Supplier Management

  • Work with current and prospective suppliers to build, maintain, and manage supplier relationships.
  • Negotiate cost-effective solutions with current and potential suppliers.
  • Contact suppliers to resolve price, quality, and delivery or invoice issues.
  • Ensure supplier compliance with corrective actions.

Inventory Control and Planning

  • Ensure that all materials are received in a timely manner.
  • Coordinate return of nonconforming materials to suppliers and contractors.
  • Manage component supply and inventory levels.

Job Requirements:

  • Experience in purchasing
  • Experience with Quality Systems standards is required.
  • Medical device industry background preferred.
  • NetSuite experience preferred.
  • High level of self-motivation, organization, self-discipline, and autonomy.
  • Able to work in a dynamic environment.
  • Detail oriented and works well with others.

Apply Today!

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