Contract jobs Quality/Validation/Systems/Software/Risk Engineer/Regulatory

Systems Ally - Boston, MA

Full-time | Part-time | Temporary | Contract | Internship$35 - $75 an hour
EducationSkills

Positions: Quality assurance, Product development, Regulatory Affairs, R&D engineer, Software and Systems engineer, Cybersecurity, Manufacturing, Computer System Validation, Verification & Validation engineer, Risk management, Pharmacovigilance, Medical device Systems Engineer, human factor engineer
Duration: 6 month to 1 year or over 1 year contract
Industry: Medical device, Pharmaceutical, Biotech
Location: Boston, Chicago, Minneapolis, San Francisco, Los Angeles, Atlanta, Jacksonville, Miami, Milwaukee, Dallas, Houston
Pay: Hourly (depended on experience in medical device, pharmaceuticals, biotech companies and fit for the position)

Experience: (in medical device, pharma and biotech is preferred)
- 0-15 + years of Quality assurance, Product development, Regulatory Affairs, R&D engineer, Software and Systems engineer, Cybersecurity, Manufacturing, Computer System Validation, Verification & Validation engineer, Risk Management, Pharmacovigilance experience, human factor engineering
- No Experience or Experience within the Medical Device, Pharmaceutical, Biotech, Automotive, Aerospace, Software, Cybersecurity Contract manufacturing Industries
- No Experience or Experience with FDA regulations (CFR 820 Design controls), European regulations (EU MDR/MDD), Risk Management 14971/ICH Q9/TIR57, Human Factor 62366, Software SDLC 62304, UL2900, IEC 60601, CSV 21 CFR Part 11/Annex 11/GAMP 5, GxP requirements (GLP, GCP, GPvP, GDP), international GMP regulations, cGMP’s, 21 CFR Parts 504, 803, 807, 820, 11, FDA Design Control Guidance, FDA General Principals of Software Validation, ISO 14971 and ISO 13485, MDSAP, MDR, ISO 62304, and global quality systems

- EU MDR (European Union Medical Device Regulation), post market surveillance, clinical evaluation report, risk benefit analysis
- No Experience or Experience with Complaints Handling, Investigations, Deviations and CAPA, Computer System Validation
- Familiar with FDA/GMP requirements and Quality Systems Compliance. Experience with tools like JIRA, Cognition Cockpit, IBM DOORS, JAMA, PTC Windchill, Easy BI, Tableau

- B.S. or M.S. Degree in Biomedical Engineering, Bio-Engineering, Biotechnology & Chemical Engineering, Mechanical or Electrical Engineering, Software Engineering, Engineering Management, Production Engineering, Networking or Cybersecurity or any other engineering/science discipline
- Excellent communication skills

Job Types: Full-time, Part-time, Temporary, Internship, Contract

Salary: $35.00 to $75.00 /hour

Contract Renewal:

  • Likely

Full Time Opportunity:

  • Yes

Internship Compensation:

  • Pay