Jun 06, 2022

Quality Engineer (QE)

$70,000 - $90,000 yearly
  • BiVACOR Inc
Full time Quality Regulatory R&D

Job Description

BiVACOR is a young start-up eager to advance our products from laboratory to clinic. We are committed to establishing Quality Assurance practices that are supportive of our ongoing R&D activities. Now seeking a motivated experienced Quality Engineer team member to contribute to this dynamic project in our Huntington Beach Office CA.

The Quality Engineer (QE) will support preparation and review of documentation and inspection required for manufacture and test of the Total Artificial Heart (TAH) system and will work with the team to assist in implementing a QM system in accordance with ISO 13485 and 21 CFR 820.


The QE will work on daily Quality Assurance (QA) activities by supporting creation and review of work instructions, inspection instructions, test protocols, and process Design Change Orders (DCO). The QE will also support inspection activities both internal at BiVCOR and its suppliers. The QE will work closely with the internal engineering staff to the support manufacturing and testing including documentation and process improvements.


For the location in Huntington Beach (CA), BiVACOR is looking for motivated and flexible team members, who are keen to contribute to this active and dynamic project. Strong organizational, time management, and technical skills paired with an analytical and problem-solving thinking in a deadline driven environment is needed. This role requires the ability to work with minimal supervision.


To be successful for this role you MUST:

  • have 3 to 5 years years' quality engineering experience in medical device development; and
  • work at the BiVACOR Huntington Beach Office CA.

RESPONSIBILITIES


- Develop and review travellers, work instructions, test procedures and reports for the manufacture and inspection of TAH system components

- Prepare and review test protocols and reports necessary for the Verification and Validation testing.

- Create, edit, and maintain documentation related to design controls and quality system guidelines including Standard Operating Procedures (SOPs), Design History Records (DHR), and Design Change Orders (DCO)

- Conduct and support inspection of components, including kitting and inventory control

- Support and conduct root cause and corrective action to improve manufacturing and test processes

- Interact with external suppliers/vendors

  • Perform supplier audits and participate in supplier visits.
  • Define, develop and implement processes and technical solutions to support current product designs, optimize manufacturing /reliability, and improve quality.

REQUIREMENTS


- Bachelor’s degree or higher in Mechanical Engineering or similar, (essential)

- At least 3 – 5 years’ quality engineering/assurance work experience in medical device development (essential) or quality assurance with Class III medical device experience (desirable)

- Experience with manufacturing engineering (desirable)

- Experience in developing work instructions, performance specifications, and verification and validation test protocols and reports (essential)

- Good verbal and written skills (essential)

- Working knowledge of quality systems, risk management tools and applicable standards, such as 21 CFR Part 820 and ISOs 14708, 17025, 14971, 13485 (desirable)

- Working knowledge of gauges and precision inspection equipment/instruments (essential)

- Previous experience in a Quality Assurance role with experience through all phases from product conception through commercialization (desirable)

- ASQ Quality Inspection Certificate (desirable)

- Proficient with Microsoft Office (desirable)


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