Senior Quality Systems Specialist - Cary, IL - Stryker Corporation

Date de publication : 1/11/2020

Résumé de l'offre

Description de l'offre

Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a Senior Quality Systems Specialist to join Stryker's Sage division in Cary, Illinois.

Who we want

  • Self-directed innovators. 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.
  • 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 requirements squarely in focus, people who deliver safe and robust solutions.

What you will do

As a Senior Quality Systems Specialist, you will be responsible for oversight of the divisional NC/CAPA program. You will also lead and direct compliance-related projects with varying degrees of complexity and interface with stakeholders across business including, but not limited to:  RA/QA, GQO, GQO Quality, GQO Supplier Quality, Marketing and NPD.    

Responsibilities include:

  • Responsible for oversight and execution of the NC/CAPA program within the TrackWise enterprise system
  • Responsible for oversight of NC/CAPA Specialist training at the Sage site and assurance that NC/CAPA Specialist training and qualifications meet all local and corporate requirements and standards
  • Responsible for oversight and maintenance of KPIs and metrics associated with the Sage NC/CAPA program
  • Coordinates and collaborates across Division and GQO to identify compliance trends, escalate issues, and report NC/CAPA metrics in various forums with the intent to educate and inform
  • Site-wide communication related to changes and requirements associated with upgrades to the TrackWise enterprise system
  • Responsible to improve team performance by building team cohesiveness, leading, influencing, training, mentoring, and motivating to facilitate cooperation, ensure efficiency, and boost morale
  • Creates and maintains appropriate program documentation (e.g. charter, roadmap, benefits map, KPIs, metrics reporting, etc.) to meet business goals and program objectives
  • Coordinates with partners and end users to deliver values to business through opportunity identification, solution delivery, and ongoing support
  • Responsible for program budget estimation, monitoring, and attainment, as appropriate
  • Communicates and sets expectations across divisions, functions, third party vendors, consulting partners, project teams, and stakeholders depending on program needs
  • Creates and maintains a program risk assessment to ensure program risks are identified and closed
  • Responsible for resource planning, as appropriate, including workload allocation and capacity planning to help determine project sequencing in the program
  • Work with constituent project managers or associates to monitor cost, schedule, and technical performance of component projects and operations, while working to ensure the ultimate success of the organization's business objectives
  • Assess trade-offs for changes to project scope, schedule, and costs that impact the program and related projects
  • Act as an escalation point, drives collaboration to resolve conflicts, project issues, and deviations to drive them to resolution
  • May be responsible for managing project managers and project personnel, as well as leading indirect resources

What you need

  • Bachelor's degree in a science, engineering or related discipline
  • 3+ years experience in manufacturing environment or equivalent
  • Experience in regulated environment
  • Strong knowledge and understanding 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

You may also have

  • Trained or certified in Lean Six Sigma or PMP certification
  • Masters or advanced degree
  • Proven ability to implement large-scale projects on a broad scale

Work From Home: Not available

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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