Staff CAPA Specialist in San Jose, CA at Stryker Corporation

Date Posted: 11/15/2019

Job Snapshot

Job Description

Who we want
Dedicated achievers.
 People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
Goal-oriented developers. Keeping the customer and system requirements squarely in focus, people who deliver safe and robust solutions.
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.

Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

User-focused creators. People who imagine with the user in mind, developing technology that helps change patients’ lives.

What you will do

The Staff Specialist, CAPA will be primarily responsible for the oversight of the CAPA process and procedures, and ensure it is compliant, effective and efficient in dealing with quality issues. The Staff Specialist, CAPA will, through expertise in problem solving methodology, facilitate proactive and effective resolution of issues.

Responsibilities:

  • Have responsibility for review and approval of NC and CAPAs, with attention to detail, review for completeness, accuracy, effectivity and timeliness. Review & Approval of CAPA changes including extension requests.                                                                                                           
  • Liaise with relevant functional groups, facilitate and mentor teams through all stages of the NC / CAPA process.
  • Contribute in developing optimum future state of the NC / CAPA process for business needs, aligned with Corporate
  • Develop & deliver training and coaching for new CAPA users on CAPA principles and on the system
  • Coordinate between potential different organizations which have to interface
  • Ensuring users provide the necessary rigor to the eCAPA system content including maintaining a live document with all relevant evidence attached, in a timely manner.
  • As Problem Solving Methodology expert,  facilitate and coach NC & CAPA teams in the application of problem solving techniques and promote its use and development e.g. Human Error Reduction, 4-D etc.
  • Subject Matter Expert on all related procedures, ensuring compliance to the relevant Corporate procedures. Super user of eCAPA system.                                                                 
  • Lead & execute the NC/CAPA Review board forums. Chair and lead Global/ multi-site forums.                                        
  • Manage & monitor site NC/CAPA KPIs including reporting requirements, provide detailed updates and information in support of quality & business review forums, also liaising with other GQO sites to ensure compliance to global requirements & metrics are achieved.
  • Ensure adequate training is developed, maintained and provided to all users of CAPA process & systems.                                                                                                            
  • Identify and lead continuous improvement and collaboration opportunities, promoting development and implementation of quality data and reports for improvement and optimization of business processes / results.
  • Provides review and input into global procedures.
  • Identify opportunity for improvement, lead &/or participate in cross-plant and corporate project teams in areas of CAPA and quality systems improvement.
  • Lead/coordinate preparation, participate and follow up to Stryker Internal, Corporate and third party compliance audits.

What you need

Basic Qualifications:

  • Bachelors Degree.
  • Minimum 4 years’ experience in working in a highly regulated environment, quality, manufacturing or engineering.

Preferred Qualifications:

  • Experience working in a regulated environment required.
  • Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) required.
  • Thorough knowledge and understanding of US and International Medical Device Regulations.
  • Strong knowledge of supporting Quality Systems (e.​g.​ Audits, Management review, Quality Planning).
  • Must possess strong communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously.
  • Strong interpersonal skills, with demonstrated ability to manage and interact with multiple stakeholders at different levels / areas of a global organization.
  • Strong written and oral communication and negotiations skills.
  • Strong in critical thinking and "outside the box" thinking.
  • Highly developed problem solving skills, demonstrated successful resolution of issues at project level.
  • Strong analytical skills.
  • Demonstrated successful management of complete.
  • Demonstrated ability to work independently, under minimal supervision in a demonstrated proactive manner.
  • Demonstrated experience and success in working in a compliance risk situation, with successful outcomes.
  • Demonstrated knowledge of U.S. Food and Drug regulations, as well as of European and international regulatory/industry guidelines/standards, and ability to interpret and apply.
  • High level of PC skills. Proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.

Work From Home: Not available

Travel Percentage: 10%

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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