What are the responsibilities and job description for the Senior Quality Engineer position at Simply Biotech?
Senior Quality Engineer- Simply Biotech
OVERVIEW
Are you looking for a new career opportunity with an exciting biotech company?! Then we've got the right team for you! In this role, you're responsible for the duties listed below.
Immediate opening for a Senior Quality Engineer with a biotech company in Snoqualmie, WA who possesses:
- Bachelor's degree in a Quality, Engineering, or related discipline (Computer/Software, Biomedical, Mechanical, Electrical).
- 5 years of experience with medical device regulatory and quality and Quality Management Systems.
- 7 years related Quality / Engineering work experience.
- Experience maintaining Technical Files, GSRPCs, Risk Management Files, Usability Engineering Files, Design History Files, MVP's, and Change Control documentation.
Email resumes to adunlop@simplybiotech.com or call 858.251.3562
FULL DESCRIPTION: Senior Quality Assurance Managers are responsible for maintaining a quality- and results- centric company culture that drives customer satisfaction, employee satisfaction, meaningful regulatory compliance, and continually improving operational excellence. This shall be done by inspiring employees to achieve to their potential, fostering the achievement of company goals by organized teamwork, and demonstrating operational excellence via leadership to support company quality policies and goals. They also seek to maintain operations that efficiently and effectively surpass strategic business planning and performance objectives.
The selected candidate will be responsible for:
- Design Control
- Manufacturing
- Material Review Board
- Installation and Service
- QMS Administration
The selected candidate will also possess:
- Bachelor's degree in a Quality, Engineering, or related discipline (Computer/Software, Biomedical, Mechanical, Electrical).
- 7 years related Quality / Engineering work experience.
- 5 years of experience with medical device regulatory and quality and Quality Management Systems.
- Experience maintaining Technical Files, GSRPCs, Risk Management Files, Usability Engineering Files, Design History Files, MVP's, and Change Control documentation.
- Experience with statistical analysis.
- Knowledge of Software as a Medical Device (SaMD) or Software within a device required.
- Experience working with teams under design controls and during new product development to follow the QMS and comply with current regulations and standards.
- Proven ability to communicate effectively with staff at all levels of the organization.
- Self-motivated and organized.
- Experience acting as a Change Agent.
- Experience with FDA 21 cfr 820, 21 cfr 11, 21 cfr 806, MDD, MDR, MDSAP, EN ISO 13485, EN ISO 14971, IEC 62366-1, EN ISO 15223, EN ISO 20417, EN 62304, Cybersecurity, IEC 60601-1, ISO 27001 and 14001.
- Experience with medical device electrical safety standards.
- Creative problem solving, flexibility, and good negotiation skills.
- Some travel may be necessary both domestic and international, less than 5%.
Salary Range: $125k-$180k/yr
For immediate and confidential consideration, please email your resume to adunlop@simplybiotech.com or call 858.251.3562 More information can be found at www.simplybiotech.com
Salary : $125,000 - $180,000
