This site uses cookies. To find out more, see our Cookies Policy

Senior Quality Systems Specialist in Redmond, WA at Stryker Corporation

Date Posted: 1/30/2019

Job Snapshot

Job Description


POSITION OVERVIEW:

Primarily responsible for the development of the quality management system in accordance with relevant regulatory requirements for medical devices. Oversee, support, and ensure that an effective and efficient quality management system is built and maintained. Responsibility for ensuring that all applicable quality system regulations are met to receive regulatory clearance/certification.

KEY RESPONSIBILITIES:

  • Supports QMS compliance with the appropriate internal and external regulatory requirements (including but not limited to Site, Division, Corporate, FDA, ISO, MDD, and individual country requirements).
  • Contribute to the development of optimum future state of QMS for business needs.
  • Identify improvements and inputs into the quality planning process.
  • Oversee and execute development and/or modification of Stryker's QMS.
  • Support Management Review and Quality Planning Review and related forums.
  • Assess and quantify requirements for QMS requirements to optimize structure.
  • Drive GMP and GDP within Quality organization.
  • Identify and implement improvement opportunities to increase the efficiency and effectiveness of the QMS.
  • Develop and deliver training for QMS areas of expertise.
  • Contribute to the development, maintenance, and improvements of policies and procedures.
  • Implement best-in-class practices and benchmark against industry leaders and regulatory requirements.
  • Liaise and communicate with notified bodies to manage certification changes.
  • Ensure QMS reflects actual activities, business needs and supports NPD requirements.
  • Engage in relevant QMS IS discussions.
  • Basic project management understanding.
  • Key contributor to QMS business process(as) and IS system support requirements.
  • Support internal and external quality system audits.
  • Understands system integration.
  • Support IS change control assessment and approval.

BASIC QUALIFICATIONS:

  • Bachelor’s Degree is required.
  • Minimum 3 years’ experience in quality, manufacturing or related work experience.

PREFERRED/DESIRED QUALIFICATIONS

  • Bachelor’s Degree preferably in a science, engineering, business or related discipline.
  • Experience in regulated environment and interaction with regulatory agencies.  
  • Thorough knowledge and understanding of US and International Medical Device Regulations.
  • Strong knowledge of Quality Systems (CAPA, audits, Management Review, Quality Planning, etc.).
  • Strong communication, project management and influencing skills.
  • Ability to plan, organize, and implement multiple concurrent tasks.
  • Strong interpersonal skills, written, oral communication and negotiations skills. Must demonstrate the ability to effectively communicate up/down and across different levels of the organization.
  • Analytical and problem-solving capabilities with the ability to draw insights from data quickly and to define executable actions.
  • Demonstrated ability to work in cross-functional team environments.
  • Basic understanding of compliance risk situations.
  • Computer literacy.

WORKING CONDITIONS:

  • 10% travel may be required.

Work From Home: No

Travel Percentage: None

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