Senior Quality System Analyst in San Jose, CA at Stryker Corporation

Date Posted: 10/19/2018

Job Snapshot

Job Description

Who we want

Strategic. Creates alternative ways to proceed. Faced with any given scenario, can quickly spot the relevant patterns and issues.

Achievers. Thrives on accomplishing tasks and constantly driven to do more.

Communicators. Articulates well and expresses ideas effectively.

Collaborators. Collaborates and builds relationships with internal and external stakeholders.

Teammates. Supports, encourages, and inspires others.

What you will do

Responsible for monitoring and improving the quality and efficiency of post market regulatory compliance systems such as complaint handling, MDR/MDV filing, field actions, and competent authority inquiries; 

  • Aid Business partners in problem solving activities including CAPA and Internal Audit
  • Lead discussions about the current state of the Quality system and help make CAPA determinations
  • Aid Business partners in determining proper metrics and thresholds to ensure health of the quality system
  • Own official quality plan projects and / or tasks
  • Lead system wide projects that may cross functional and/or division lines
  • Review and analyze data for trending purposes
  • Work from verbal and/or written instructions.
  • Act independently to determine daily activities and project implementation
  • Work as a team member on the CAPA and Internal Audit teams
  • Advise Management on best practices and resource allocation
  • Participate in Internal and External Audits

What You Need

  • Working knowledge of data collection, data analysis, evaluation, and scientific method.
  • Engineering schematics/drawing/prints reading and interpretation
  • Commitment to excellence and high standards
  • Excellent organizational, problem-solving, and analytical skills to lead to sound, timely decisions
  • Ability and versatility to manage changing priorities and workflow for multiple projects and deadlines
  • Ability to interface with both technical and non-technical personnel at all organizational levels.
  • Proficient with Microsoft Office and ability to learn corporate systems.
  • Ability to understand and explain detailed regulatory compliance programs and/or issues.
  • Ability to comply with constantly changing regulatory procedures and prioritize work effectively.
  • Ability to analyze and resolve non-routine regulatory issues using independent judgment.
  • Must be able to observe and correct minute inconsistencies (e.g. in the written word, form usage, etc.).
  • Self-motivated.


  • 2+ years experience in medical device, biologics and/or pharmaceutical field.
  • Bachelor’s degree in engineering, life sciences, nursing or related field.


  • Master’s degree in engineering, life sciences or nursing (mechanical, electrical, industrial, software, biomedical, computer, biology, physics, chemistry, etc.) preferred.
  • Previous experience in legal, technical or medically related area preferred.
  • Knowledge of applicable international regulations and standards (CFR, MDD, QSR, ISO 13485, CMDCAS, etc.) preferred
  • Regulatory Affairs Certification desired.

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.

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