Remote Software Quality Engineer (Biotech)

Proclinical is seeking a Software Quality Engineer for a privately owned biotechnology company based in Vancouver, BC that supports research in the fields of immunology, hematology, neuroscience, mesenchymal cell, stem cell and epithelial cell biology. This position is remote based, but also open to candidates who would be interested in moving to the Vancouver area.

Job Responsibilities:

• Act as the Subject Matter Expert (SME) of Software Lifecycle Design SOP and ensure software elements of the QMS are up-to-date with the relevant regulatory requirements and IEC 62304.
• Serve as a Core Team Member to review Software DHF documentation and provide strategic input to the Software Development team.
• Create Software Development Plans and ensure all Design Control deliverables are met according to the Software Development Plan.
• Participate in the system requirements review and in creating sub-system & software requirements with the project team.
• Work closely with Software Development to lead Software Risk Assessment activities and create the risk assessment documents (DFMEA, UFMEA).
• Participate in design reviews and code analysis, and support the development of design and architecture documentation required by industry standards and regulatory.
• Monitor Change Control activities associated with product software throughout the project life cycle.

Skills and Requirements:

• Education: BS in Biomedical, Software, or Computer Engineering, or other technical discipline
• At least 4+ years' experience in the regulated medical device industry or equivalent including experience with the Software Lifecycle regulatory guidance.
• Experience utilizing Software Development tools and associated systems for requirements management preferred.
• In depth knowledge of IEC 62304, ISO 14971, 21 CFR part 11.
• Familiarity with 21 CFR 820, ISO 13485, IEEE standards preferred
• Understand requirement trace matrix and configuration management concepts.
• Excellent technical report writing and strong ability to understand and analyze technical documents.
• Other characteristics: Comfortable making presentations before groups; ability to question and not be always satisfied with the status quo; willingness to learn and assume new responsibilities; good interpersonal skills; self motivated and independent work ethic; ability to handle multiple tasks in a fast paced environment.
• Must have experience with product development and design control (Understanding of NPI and design control process- 1-2 years minimum)
• Understanding of the IEC 62304 and 21 CFR part 11 standards

If you are having difficulty in applying or if you have any questions, please contact Jax Zafrani at (+1) 213-893-4997 or j.zafrani@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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