Quality Systems Analyst in Portage, MI at Stryker Corporation

Date Posted: 9/17/2019

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.

Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.

What you will do

As a Quality Systems Analyst, you will be responsible for leading the management of our Quality System. This includes leading us through our Internal Audits to drive continuous improvement to the processes of our Quality System and managing changes to the documents and working with SMEs and process owners through those changes. This role will interact with all areas of our business to drive regulatory compliance of our processes while innovating and driving actions to generate continuous development and improvement of the processes.

Quality Systems / Process and Project Management:

  • Maintain compliance of our Quality System in collaboration with SMEs, Divisional Process Owners, and the Corporate Quality System.
  • Support SME’s in the creation or updating of our quality systems content while maintaining compliance to our quality system.
  • Develop and guide ownership of our SMEs to the Quality System processes and their documents.
  • Lead and provide training associated with the understanding and management of our Quality System.
  • Identify opportunities for enhancement of existing quality and regulatory systems/tools in support of our departmental and divisional visions. 
  • May Lead/Support the Internal Audit process.
  • Support the coordination training requirements and release of changes with Training Specialists and Process Owners.
  • Provide quality support as a consultant to our organization to build understanding of quality concepts and drive our quality culture.
  • Drive improvements and support of changing regulations/requirements of our quality system content and processes.
  • Support any training needs regarding the quality system documents in collaboration with our learning and development systems/teams.

Quality Management and Continuous Improvement:

  • Support data analysis to identify or lead quality improvements of our systems or processes.
  • Drive continuous improvement for Quality System processes by identifying efficiencies and methods of reducing costs.
  • May support the coordination of any major changes to the business and quality system which may impact the structure, content, or its databases
  • May own/manage NC/CAPAs for identification, scope, investigation, root cause,  and planning
  • Business Unit Highlights – Deliver or support the Monthly/Regular recurring data analysis and trending to support Quality Plan.
  • Cost Reduction Team Support – Support initiatives as needed
  • Special Projects – As needed by Business Unit and Department

Regulatory Compliance:

  • Participate in internal compliance audits
  • Support external audits – Vendor and Sister Divisions
  • Monitor compliance to Medical Quality Procedures and FDA Quality System Regulations (QSR’s) and update as necessary

What you need

Basic Qualifications:

  • Bachelors Degree required

Preferred Qualifications:

  • Bachelor’s Degree preferably in Engineering, English, Business or Technical Writing
  • GPA of 3.0 or higher, strongly preferred
  • Previous technical writing, process mapping, and/or auditing experience a huge plus
  • Excellent communication, time management, and organization skills with high emphasis on attention to detail
  • Ability to successfully interface with various departments and personnel
  • Ability to work independently and motivated to perform at a high-level without constant supervision
  • Ability to handle multiple projects on an ongoing basis
  • Ability to adhere to necessary processes within a regulated environment
  • Ability to understand regulatory requirements and translate into internal business and quality system documentation
  • Effective analytical, problem solving, organization, and planning skills
  • Working knowledge of MS Word, MS Excel, MS Visio, and PowerPoint 2007, MS SharePoint, Adobe Acrobat, MS InfoPath 2007, and a document management software (e.g. Windchill or similar software)
  • Demonstrated written fluency in English

Work From Home: No

Travel Percentage: 0%

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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