QA Lifecycle Management Engineer
300 Bel Marin Keys Blvd. Novato, CA 94949
Bayside Solutions is seeking a QA Lifecycle Management Engineer to be part of our client’ s team in Novato. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
QA Lifecycle Management Engineer:
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- Organize, analyze and report on quality metrics for market product that contain device components and assemblies.
- Perform the required post market risk management activity to maintain the risk profile and associated controls for all device products.
- Perform periodic assessment of regulatory requirements against marketed products and associated controlled documents.
- Facilitate revisions to SOPs as required to support the current state of business.
- Support the premarket activities in the design and development of combination products.
- Experience working in a Quality Management Systems, specifically CFR Title 21 Part 820 and ISO 13485.
- Proficient with GxP practices in the Pharma and Medical Device Industries.
- Experience in working with Electronic Change Control Systems (EDMS).
- Experience in technical writing with SOPs, Work Instructions, Technical Reports, FMEA’ s.
- Experience with updating risk assessments based on product complaint data processing.
Summary of Qualifications:
- BS in engineering or sciences, or equivalent combination of education and experience would be considered.
- Proficient with computer systems using the following software; MS Word, MS Excel, MS Outlook, VISIO
- Effective communicator using verbal, written and graphical techniques
- Effective working in a cross functional group and taking notes in meetings
- Min 7 year of experience working in Pharma or Medical Device industries in a quality department role.