Senior QMS Strategy & Compliance Specialist in Allendale, NJ at Stryker Corporation

Date Posted: 7/25/2018

Job Snapshot

Job Description

As a Senior QMS Strategy & Compliance Specialist you will be responsible for maintaining foundational, medical device QMS requirements (such as the Quality Policy, Quality Manual and Quality Planning), as well as implementing quality and regulatory initiatives / projects as a subject matter expert. You will be additionally accountable for the organization of external audits by applicable regulatory authorities including planning, execution and post-audit follow-up.

  • Support QMS compliance with the appropriate internal and external regulatory requirements and maintain awareness of the overall regulatory landscape.
  • Contribute to the development of optimum, future state of the QMS.
  • Maintain the divisional Quality Manual, Quality Plans and Quality Policy, ensuring they are reflective of changes in business scope, QMS and regulatory requirements, and appropriately utilized through the division.
  • Support Management Review and Quality Planning reviews and related forums.
  • Identify and implement improvement opportunities to increase the efficiency and effectiveness of the QMS.
  • Oversee and execute developments and / or modifications to Stryker Spine’s QMS.
  • Act as liaison and communicate with notified bodies / health authorities in regard to audits, certification changes, and other periodically required communications. 
  • Act as a SME during internal and external audits for responsible processes.
  • Plan and support all elements of external audit planning, execution and close out / follow-up

Minimum Qualifications

  • BA, BS or equivalent (emphasis in engineering, sciences, quality or related discipline preferred). 
  • Quality and / or regulatory affairs certifications such as RAC, CQA, CQE, etc. are preferred.
  • 3 years or more of experience in the medical device industry or an equivalent regulated environment, with a focus on quality systems and / or regulatory affairs. 
  • Thorough knowledge and understanding of US and international medical device regulations, including those of the EU and MDSAP regions.
  • Knowledge of regulations, standards and industry practices associated with human and animal tissue is advantageous.
  • Experience participating, supporting and / or organizing internal and external audits is preferred, as is experience interacting directly with regulatory authorities or notified bodies.
  • Strong knowledge of quality systems (Quality Planning, Management Review, Internal Audit, CAPA, Document Controls, etc.) 
  • General understanding of global, device market authorization practices / processes.
  • Strong communication, organizational and influencing skills and a demonstrated ability to work in cross-functional team environments.
  • Ability to plan, organize and implement multiple concurrent tasks.
  • Ability to effectively communicate up / down and across different levels of the organization.
  • Analytical and problem-solving capabilities with the ability to strategize, identify and assess foreseeable impacts, and to define executable actions.
  • Basic understanding of project management.

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.

Join our talent network

Joining our talent network will enhance your job search and application process. Whether you choose to apply or just leave your information, we look forward to staying connected to you.

Join Our Team