Staff Quality Systems Specialist (Hybrid)

Mahwah, NJ - USA

Monthly Salary: $ 92600 - 148400

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Work Flexibility: Hybrid

Stryker is hiring a Staff Quality Systems Specialist (Hybrid) to join the team in Mahwah NJ. This is a hybrid role and candidates must live within a reasonable commuting distance to the site. The role is highly visible and requires strong engagement across leadership HQ and cross-functional teams.

What you will do

Ensure QMS compliance with internal and external regulatory requirements (FDA ISO MDD country-specific).
Develop and implement future-state QMS strategies aligned with business needs.
Identify and drive improvements through the quality planning process.
Lead development and modification of QMS processes and documentation.
Act as a subject matter expert during internal and external audits.
Plan and support external audit activities including execution and follow-up.
Manage a Management Review and Quality Planning Review forum.
Assess and implement structural improvements to optimize QMS efficiency.
Benchmark best-in-class practices and ensure alignment with regulatory expectations.
Liaise with notified bodies to manage certification changes.
Coordinate QMS activities to support project milestones and NPD requirements.
Lead QMS strategy execution and improvement initiatives.
Represent QMS expertise during audits and IS system change assessments.

What you need

Bachelors degree in science engineering business or related discipline.
Minimum of 5 years of experience in a manufacturing environment or equivalent.
Strong knowledge of Quality Systems (CAPA audits Management Review Quality Planning etc.).
Experience in a regulated environment and interaction with regulatory agencies.
Experience performing and managing external audits by Notified Bodies Regulators or other Agencies / Accreditors.
Thorough knowledge and understanding of US and international medical device regulations.

Preferred

Experience in compliance risk situations.
Strong knowledge of system integration and IS system support requirements.
Strong communication project management and influencing skills.
Ability to plan organize and implement multiple concurrent tasks.
Strong interpersonal written oral communication and negotiation skills.
Analytical and problem-solving capabilities with the ability to draw insights from data and define executable actions.
Demonstrated ability to work in cross-functional team environments.

$ 92600.00 - 148400.00 salary plus bonus eligible benefits. Individual pay is based on skills experience and other relevant factors.

Travel Percentage: 20%

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 contractors legal duty to furnish information.

Required Experience:

Staff IC

Work Flexibility: HybridStryker is hiring a Staff Quality Systems Specialist (Hybrid) to join the team in Mahwah NJ. This is a hybrid role and candidates must live within a reasonable commuting distance to the site. The role is highly visible and requires strong engagement across leadership HQ and c...

Work Flexibility: Hybrid

What you will do

Ensure QMS compliance with internal and external regulatory requirements (FDA ISO MDD country-specific).
Develop and implement future-state QMS strategies aligned with business needs.
Identify and drive improvements through the quality planning process.
Lead development and modification of QMS processes and documentation.
Act as a subject matter expert during internal and external audits.
Plan and support external audit activities including execution and follow-up.
Manage a Management Review and Quality Planning Review forum.
Assess and implement structural improvements to optimize QMS efficiency.
Benchmark best-in-class practices and ensure alignment with regulatory expectations.
Liaise with notified bodies to manage certification changes.
Coordinate QMS activities to support project milestones and NPD requirements.
Lead QMS strategy execution and improvement initiatives.
Represent QMS expertise during audits and IS system change assessments.

What you need

Bachelors degree in science engineering business or related discipline.
Minimum of 5 years of experience in a manufacturing environment or equivalent.
Strong knowledge of Quality Systems (CAPA audits Management Review Quality Planning etc.).
Experience in a regulated environment and interaction with regulatory agencies.
Experience performing and managing external audits by Notified Bodies Regulators or other Agencies / Accreditors.
Thorough knowledge and understanding of US and international medical device regulations.

Preferred

Experience in compliance risk situations.
Strong knowledge of system integration and IS system support requirements.
Strong communication project management and influencing skills.
Ability to plan organize and implement multiple concurrent tasks.
Strong interpersonal written oral communication and negotiation skills.
Analytical and problem-solving capabilities with the ability to draw insights from data and define executable actions.
Demonstrated ability to work in cross-functional team environments.

$ 92600.00 - 148400.00 salary plus bonus eligible benefits. Individual pay is based on skills experience and other relevant factors.

Travel Percentage: 20%

Required Experience:

Staff IC

Key Skills

Quality Assurance
FDA Regulations
Data Collection
Food Safety Experience
ISO 9001
Mobile Devices
Root cause Analysis
Quality Systems
OSHA
Food Processing
Quality Management
cGMP

Apply Now

About Company

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. Alongsid ... View more

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