Job Title - Quality Engineer III
Location - San Diego, CA
Duration – 12+ Months Contract
Total Hours/week - 20.00
1st Shift
PT position 20 hrs. week, onsite position, not remote. flexible with scheduling
Description:
The Quality Engineer III position will be accountable for supporting the BD Custom Technology Team's conversion from ISO 9001:2015 to ISO 13485:2016. As part of the project team, this role will identify gaps, prioritize actions using risk based approach, and implement the required changes. This position will be responsible for applying ISO standards to help develop and implement solutions of moderate scope and complexity. Working both independently and in combination with process and equipment subject matter experts, the role will be responsible for revising existing procedures and drafting new procedures under the guidance of the project team. A minimum of 2 years previous medical device experience applying Design Control under ISO standards is required. A degree in biology or chemistry with industry application experience in antibody manufacturing and/or Immunology is preferred. A successful candidate will be a strong oral and written communicator with expertise in risk assessment techniques (FMEA, etc.), process validation, environmental controls and Quality Systems.
Top skills required
1. Documented knowledge of and experience with ISO 9001 and/or ISO 13485
2. Medical Device risk analysis and validation experience
3. Strong Microsoft Office skills including Word, Excel and Visio
4. Project experience in a lead or responsible member capacity
5. Assertive ability to communicate with SMEs to define processes