This position will support a San Francisco acquisition and is a termed role of 18-24 months
As a Staff Engineer Quality Assurance you will support daily Quality Engineering activities for successful achievement of long-term company quality objectives. You will support sustaining engineering activities for products and/or processes that relate to commercial products.
This will include; manufacturing transfer programs, investigation of nonconformances, ensuring CAPA investigations and actions ae completed, creating and reviewing change orders, reviewing design history files, verification test results, supporting, revising, and creating engineering deliverables for technical files.
Relates well to all team members and can receive instruction as it relates to technical or team related matters (e.g. chemistry, communication, process, etc.).
Consistently produces results that exceed expectations in time frames that benefit the project/team.
Initiates action as it is required to ensure project/team success (e.g. mitigate risks, problem solve, provide technical guidance, etc.).
Communicates clearly and confidently with respect to technical matters both internally and with clients
Displays strong English proficiency marked by ability to comprehend/converse in real time, and by effectively presenting material or defending/articulating their position (debate).
BS Degree in Science, Engineering, or related field is required.
4+ years in related industry experience the new req is at a Staff level and this requires a min of 4 years the last post was 1+ years of exp.
Ability to work in an FDA-regulated industry.
Observe and comply with quality policies, procedures and work instructions.
Be positive, selfconfident, and decisive with excellent communication skills in both oral and written formats, as well as excellent listening skills
Be known as a person who has high integrity, sound character, a tremendous work ethic, excellent team player, and the passion to succeed
Strong technical writing skills, including advanced MS Office proficiency and Good Documentation Practices (GDP).
Recent handson experience applying methodical problemsolving techniques and fundamental statistical data analysis methods is desirable.
Ability to handle multiple tasks simultaneously and ability to manage project timelines.
Demonstrated handson medical device experience under US 21 CFR 820 requirements; working knowledge of 21 CFR Part 11 a plus.
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.