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Senior Quality Engineer (QMS Update)

Stryker

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3-5 Years
a month ago
39 Viewed
6 Applied

Job Description

Why engineering at Stryker

At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker,you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare better.Here,you will work in a supportive culture withotherincredibly talented and intelligentpeople, creating industry-leading medical technology products. You will also have growth opportunities as we have a culture that supports your personal and professional development.

Need another reason to apply Check out these 8 reasons to join Stryker's engineering team:

Who we want:

  • Self-directed imitators: People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
  • Strategic thinkers: People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.
  • Collaborative partners: People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
  • Analytical problem solvers: People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.

What you will do:

  • Experience in projects accompanying ISO 27001 and ISO/IEC 17025 certification.
  • Leading our internal and external security audits for various certification programs including ISO, IEC, SOC2, ITGC, NIST CSF, NIST 800-53, among others, to facilitate successful internal and external security audits that lead to industry certifications.
  • Ensure all the requirements, for product security laboratoriesaccreditationincluding ISO 27001 and ISO/IEC 17025, among others, are implemented, operational and mapped to SGTC quality documents. This includes annual review and updating of existing QMS Security Policies, Standards and Procedures.
  • Ability in defining and documenting policies and procedures.
  • Proven skills in conducting research, identifying gaps, writing/developing policies and procedures.
  • Strong communication and positive customer orientation skills.
  • Manage document review, comment, and approval processes, Ensure proper template, form usage and formatting.
  • Ensure adherence to the Standard Operating Procedures that govern the SGTC document management system.
  • Provide input and support for managing SGTC documentation schedules, documentation issues, etc.
  • Coordinate with cross-functional teams, ongoing compliance monitoring and evidence capture.
  • Build awareness and accountability around IT governance, risk, and compliance control functions Contribute to developing and enhancing a mature security culture.
  • Lead and report on status of security audits for various security programs, ensuring auditors are managed, and evidence is provided in a timely manner.
  • Interact and deliver strong communication enterprise-wide with all levels of personnel, including executives, business functional heads and technical staff.

What you need:

  • Bachelor's degree in computer science, IT or equivalent combination of education, training, and experience.
  • Commercial understanding of compliance industry, 3+ years of experience in quality management system, implementation of business processes including creating and revising procedures and workflows.
  • Minimum 3 years of working experience in managing QMS Information Security disciplines with ISO /IEC 27001 for Information Security Management System and ISO/IEC 17025 Testing and calibration laboratories.
  • Certifications: Lead Auditor ISO 27001, Lead Auditor ISO 17025, preferably CISM.
  • Experience working in a regulated environment and in electronic systems process flows, validation, and approval of quality documents.
  • Experience clearly articulating assignment challenges into business terms and presenting to company management.
  • Strong communication skills for various communicating at various levels in the organization.
  • Demonstrated written fluency in English.
  • Strong critical thinking skills
  • Strong accuracy and strict attention to detail
  • In-depth knowledge of and proficiency with Microsoft Office Suite
  • Team-oriented and will promote execution and change through influence and partnership.
  • Strong interpersonal communication skills
  • Passion for continuous improvement and demonstrated problem solving skills.

About Stryker
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at

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Stryker is one of the world&#8217&#x3B;s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at stryker.com and careers.stryker.com.

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