Senior Specialist. Quality Management System in Mahwah, NJ at Stryker Corporation

Date Posted: 8/15/2019

Job Snapshot

Job Description

Who we want

  • Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.
  • Data translators. Highly effective communicators who can transform data findings into recommendations to compose reports and executive level presentations.
  • Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
  • 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.

What you will do

Working within the QMS team, under general supervision, ensure compliance to CAPA processes and procedures and is responsible to, but not limited to.  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.
  • 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. Lead multi-site forums and participate in global 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 continuous improvement and collaboration opportunities, promoting development and implementation of quality data and reports for improvement and optimization of business processes / results.
  • 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

  • Bachelor’s degree in engineering or related discipline
  • Minimum of 1-4 years in role with direct exposure to Quality Management Systems.
  • Strong knowledge of Quality Systems (e.​g.​ CA​PA, Audits, Management review, Quality Planning

.

Work From Home: No

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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