Senior Staff Quality System Specialist in Cary, IL at Stryker Corporation

Date Posted: 6/19/2020

Job Snapshot

Job Description

Senior Staff Quality System Specialist

Stryker is one of the leaders in the MedTech industry and we continue to grow and evolve. Stryker has expanded beyond being a Medical Device company. The former Sage Products location in Cary designs and manufactures products across the regulated spectrum (Medical Devices, Cosmetics and Pharmaceuticals). We are looking for a talented individual to join our team in Cary, Illinois.

Want to learn more about us?

https://www.youtube.com/watch?v=heczP78LEG

https://www.linkedin.com/company/3282

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.

User-focused creators. People who imagine with the user in mind, developing technology that helps change patients’ lives.

We are looking for an individual who has the experience to share and the ability to assist with developing the team to evolve and support the growth of the business.

What you will do:

As a Senior Staff Quality System Specialist, you will primarily be responsible for the strategic development and continued evolution of the quality management system in accordance with relevant, global regulatory requirements for pharmaceuticals, biocide, cosmetic and medical device products; oversee and ensure that an effective and efficient quality management system is built and maintained while providing technical leadership; responsibility for ensuring that all applicable quality system regulations are met in order to receive and maintain regulatory clearance, certification and strong internal and external assessment results.

Responsibilities:

  • Ensure QMS compliance with the appropriate internal and external regulatory requirements (including but not limited to: Stryker site, division and corporate requirements; external regulatory bodies and standards such as FDA, ISO, MDD, ICH, Eudralex, Health Canada and individual country requirements).
  • Share your knowledge and expertise with fellow RA and QA team members, building a bench of strength in pharma requirements.
  • Ensure an optimum state of the QMS for current and future business needs.
  • Ability to assess the state of current business and RAQA operations to identify and recommend future state, improvements, and to implement action plans.
  • Drive development and/or modification of the QMS, particularly ensuring effective processes and a QMS structure is in place to efficiently meet the regulatory requirements of different product types and classes.
  • Provide guidance for the development, maintenance, and improvement to policies and procedures to increase the efficiency and effectiveness of the QMS.
  • Ensure QMS reflects actual activities, business needs and supports NPD and Drug Formulation and Technology Transfer requirements.
  • Provide direction for the overall QMS strategy. Lead improvement processes, executing and leading projects.
  • Identify and deliver strategic and futuristic improvements and inputs into the quality planning process.
  • Advise on best practices to excel in GMP and GDP compliance within Quality organization including, at times, reviewing and advising on technical content of records, such as complex change control records and CAPAs.
  • Ensure development and delivery of training for QMS areas of expertise.
  • Drive development of best-in-class practices and benchmark against industry leaders and regulatory requirements
  • Liaise with Medical Device (e.g., AdvaMed) and Pharma (e.g., PHrMA) Advocacy organizations to influence new regulations or guidances and stay abreast of upcoming shifts in regulatory policies. notified bodies to manage certification changes.
  • Researches and maintains current knowledge of applicable legal and regulatory developments, industry standards to determine emerging compliance trends and incorporates such developments, standards and trends into education and action plans.
  • Manage QMS activities to support achievement of project milestones.

What you will need:

Basic Qualifications:

  • Bachelor’s Degree
  • Minimum 7 years’ experience working in quality, manufacturing, engineering, NPD, pharmaceutical, or highly regulated environment

Preferred Qualifications:

  • Bachelor’s Degree in Science, Engineering, Business or related discipline
  • Minimum 7 years’ experience in a pharmaceutical manufacturing environment or equivalent preferred
  • Regulated environment experience and interaction with regulatory agencies required through internal and external quality system audits.
  • Thorough knowledge and understanding of US and International Medical Device, Pharma, Biocide and Cosmetic Regulations and Standards.
  • Strong knowledge of Quality Systems (Pharma and Medical Device QMS Structure, CAPA, audits, Management Review, Quality Planning, etc.)
  • Project management skills: Demonstrated ability to plan, organize, and implement multiple projects/processes efficiently at the same time.
  • Strong interpersonal skills, written, oral communication, influencing and negotiation skills. Must demonstrate the ability to effectively communicate up/down and across different levels of the organization to achieve desired outcomes.
  • Ability to builds strong relationships by fostering open communication, respect and trust.
  • Act with a customer service/stakeholder-focused approach.
  • Analytical and problem-solving capabilities with the ability to draw insights from data quickly and to define executable actions.
  • Demonstrated ability to work and promote change in cross-functional team environments.
  • Demonstrated experience facilitating and leading global process improvement and harmonization activities.
  • Present as a change agent by adopting a continuous improvement orientation.
  • Act as the voice of Quality in cross-functional teams, ensuring appropriate outcomes.
  • Some travel may be required

Work From Home: Occasional

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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