Document Control Manager
900 Island Dr, Suite 101 Redwood City, CA 94065 | Contract
Bayside Solutions is seeking a Document Control Manager to be part of our client’ s team in Redwood City. 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.
Document Control Manager:
- 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:
- Manage and set priorities for the Document Control and Training staff.
- Lead Propel software implementation including product configuration management.
- Maintain Device Mater Records for each of company’ s devices.
- Maintain BOMs and Routers configuration.
- Execute all other duties as assigned related to Document Control and Training departments.
- Develop, implement, and maintain simple and effective Engineering Change Control (ECO0 process).
- Sets goals and objectives for Document Control and Training Departments.
- Stablish and maintain policies for quality records retention program.
- Develops and implement training programs for ECO and other document control related process.
- Manage and maintain training compliance by initiating training plans, updating assessments as needed, and conducting training sessions.
- Generate quality system metrics such as ECO, Training, Non-conformances, and CAPAs for Management Reviews.
- Maintain external standards library.
- Participate in team related activities such as Design Reviews Participate in agency audits (i.e., CA FDB, FDA, and ISO).
- Can use CAD (SolidWorks) to make redline changes to part drawings.
- May be required to cross train in other areas within the Quality Department to support workload required.
- Maintains trained status for, and complies with, all relevant aspects of the company Quality Management System to ensure product quality and support regulatory compliance.
- Performs other duties as assigned.
Summary of Qualifications:
- Bachelor’ s degree or four to five years related experience and/or training; or equivalent combination of education and experience in the medical device industry.
- SolidWorks training and/or certification preferred.
- Basic working knowledge of CAD (SolidWorks) software.
- Basic knowledge of QSR documentation and records requirements.
- Ability to read and comprehend complex instructions, short correspondence, and memos.
- Ability to write complex correspondence.
- Able to effectively present information in one-on-one and small group situations to customers, clients, and senior management.
- Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.
- Ability to deal with Problems involving several concrete variables in standardized situations.