Stryker Staff Quality Systems Engineer in Fremont, California
Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com .
Stryker’s Neurovascular division is focused on advancing the practice of less invasive stroke therapies through its Complete Stroke Care solutions. The business is dedicated to providing innovative stroke products and services for ischemic and hemorrhagic stroke, and committed to providing clinical education and support to help physicians deliver better patient outcomes. Products include: stent retrievers, detachable coils, stents, balloons, guidewires and microcatheters.
In March 2018, Stryker Corporation (NYSE:SYK) announced that for the eight consecutive year has been named as one of the 2018 FORTUNE 100 Best Companies to Work For, rising to 16th place out of 100.
Together with our customers, we are driven to make healthcare better.
Who we want
Achievers. High stamina performers who thrive on being busy and productive.
Problem Solvers. People who use the right tools to develop innovative and robust solutions to challenges. Teammates. Partners who listen to ideas, share thoughts and work together to move the business forward.
Learners. People with a great desire to learn and continuously improve.
Communicators. Those who are can easily put their thoughts in to words and deliver compelling presentations.
Owners. Team members who take accountability personally; who say what they do and do what they say.
What you will do in this role:
As the DPO (Division Process Owner) for Document Control and Change Management, you will take a leading hands-on role in the implementation of the new Global document management system. This will include coordination of migration of legacy data, identification of key resources and initial system training.
On completion of the roll out, you will assume the role of primary change analyst, chairing the Change Review Board and leading the assessment of change on the QMS.
In addition to this, you will also support a range of Quality System improvement projects and activities, including identification and implementation of meaningful quality metrics and key performance indicators (KPIs) across the Division, NC/CAPA ownership, participation in the EU MDR initiative and also in the Internal & External Audit programs.
What you need
Bachelor’s degree with a minimum of 4 years in Quality/Regulatory Affairs environment with 2 years experience in interacting with regulatory agencies (FDA, BSi, etc.)
Strong knowledge of Quality Systems (e.g. Document Control, Change Control, NC/CAPA, Audits, Management review, Quality Planning)
Demonstrated knowledge of FDA regulations, MDSAP program, as well as of European and international regulatory/industry guidelines/standards, and ability to interpret and apply
Strong organization and project management skills, and the ability to operate in a high paced environment.
Work From Home: No
Travel Percentage: Up to 25%
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.
Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.
Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com