Senior Quality Engineer (Medical Device)

  • BHO Tech
  • Hayward, CA, USA
  • Apr 23, 2021
Full time Engineering

Job Description

We are a rapidly emerging biopharmaceutical company committed to developing innovative therapies that merge medicine with technology.

We seek to transform the standard of care and improve patient outcomes in major therapeutic categories for serious chronic diseases, such as diabetes. We successfully completed our Phase 3 clinical trial program for our lead product, ITCA 650, and submitted our New Drug Application filing in the U.S. in 2016. 

Additionally, we are developing a pipeline of products for our proprietary Medici Drug Delivery System, comprised of three unique technologies: 1) A stabilization technology that allows for proteins, peptides, antibody fragments, and other highly potent small molecules to be stabilized at or above human body temperatures for up to three years or more; 2) A matchstick-sized osmotic mini-pump that is placed just under the dermal layer of skin to deliver a continuous and consistent flow of medication; and 3) A placement technology including proprietary tools designed to provide an optimal user experience. 

We Are Growing

Since our 2012 round of financing, much progress has taken place, including significant enhancements to our world-class manufacturing facility, the opening of our new headquarters in Bostons Innovation Center, and the diversification of expertise on our Board of Directors and Leadership Team through new senior leaders who contribute vital new capabilities and experiences. 

A key element of pride during our progress has been our ability to remain fully independent throughout our rounds of financing so that we continue to have full strategic and executional control over all aspects of our rapidly evolving business. While we are always accountable to our stakeholders, we are and intend to remain the driving vision and force behind our progress and our ultimate success. 

Your Opportunity

As a key member of the Quality Assurance Team, the Senior Quality Engineer, Medical Deviceis to assume a lead role in providing Quality Engineering support for New Product Development projects. The Senior Quality Engineer is responsible for facilitating compliance to applicable internal and external requirements during the product development cycle and commercialization of new products. 

Duties and Responsibilities:

Responsible for day-to-day administration of the QMS and in the development, implementation, and maintenance of QMS processes to meet the requirements of U.S. FDA (e.g. 21 CFR Part 820, Part 4), and other applicable quality and regulatory standards (e.g. ISO 13485, MDD, ISO 14971).

  • Perform Design Control activities; ensure design control documentation and design change control requirements are met and appropriately traced throughout the development process and in the design history file.
  • Drive the creation of an appropriate Risk Management Plan at the start of a project and maintain the plan through all phases of development; support risk assessment activities through AFMEA, DFMEA, PFMEA and other QA risk analysis techniques in order to manage potential risk during development and commercialization
  • Support manufacturing site inspections/audits for compliance with Design Controls of Combination Products.
  • Write and approve Quality Systems SOPs, Protocols and Reports to support all activities associated with Design Control
  • Support various QMS activities including complaint handling, CAPA, internal and external audits, quality metric/dashboard development and maintenance.
  • Identify quality improvement opportunities within areas of responsibility. Coordinate and participate in key quality initiatives, as appropriate.
  • Provide analysis for Management Review (gathering metrics, creating charts and providing information)
  • Provide strategic input to design development activities (Biocompatibility Testing, Packaging Testing, Sterilization Validation, Stability Testing, Statistical Sampling etc.)

Qualifications:

  • Must have working knowledge of CFR 820, CFR 4, ISO 13485, ISO 14971, and MDD
  • Have working knowledge of sterilization, biocompatibility, and transit/shelf life standards a plus
  • Have mechanical skills and have the ability to solve problems effectively
  • Computer skills are needed, with experience using Microsoft Access, Word, Excel, PowerPoint, and Project
  • Must have knowledge of statistics and application of statistical methods using Minitab, Jump, etc.
  • Understand design, development, verification and validation processes
  • Ability to listen effectively and utilize various modes to communicate with employees at all levels, suppliers, and potentially customers
  • Be a collaborative team member and an advocate for product quality and compliance
  • Demonstrate accuracy and thoroughness to improve and promote quality; apply feedback to improve performance; and monitor own work to ensure quality

Education and Experience:

  • Bachelor's degree in engineering or related field or equivalent work experience required
  • 5+ years of quality experience in a medical device or combination product required, including design controls, product/process validation, and technical problem solving
  • CQA or CQE is a plus


Best Regards,
Kris
Kris Young
Account Manager
BHO Tech
San Jose, San Francisco Ca
Phone: 866 816-1615 x 823
kris@bhotech.com
www.bhotech.com