Quality System Specialist
Mahwah, NJ

Job Description

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 System Specialist, you will support the development of quality management system processes in accordance with relevant regulatory requirements for medical devices. Ensure effective and efficient execution of quality management system processes including, but not limited to change management and master data maintenance.

Responsibilities:

* Support QMS compliance with the appropriate internal and external regulatory requirements (including but not limited to Site, Division, Corporate, FDA, ISO, MDD, and individual country requirements).
* Engage in the development of optimum future state QMS processes for business needs.
* Identify improvements and inputs into QMS processes.
* Execute QMS and master data changes.
* Support QMS related forums through data preparation and analysis.
* Support GMP and GDP within Quality organization.
* Identify and implement improvement opportunities to increase the efficiency and effectiveness of the QMS.
* Support QMS training development and delivery.
* Contribute to the development, maintenance, and improvements of policies and procedures.
* Support implementation of best-in-class practices and benchmark against industry leaders and regulatory requirements.
* Ensure QMS reflects actual activities, business needs and supports NPD requirements.
* Participate in relevant QMS IS discussions.
* Demonstrate basic understanding of project management concepts.
* Serve as key contributor to QMS business process(es) and understand IS system support requirements.
* Support internal and external quality system audits.
* Demonstrate basic understanding of system integration concepts.
* Support IS change control assessment and approval.

What you need

Basic Qualifications:

* Bachelors Degree

Preferred Qualifications:

* Bachelor's Degree in a science, engineering or business-related discipline.
* Experience in Quality Systems, manufacturing or equivalent environment.
* Knowledge and understanding of US and International Medical Device Regulations.
* Knowledge of Quality Systems (CAPA, audits, Management Review, Quality Planning, etc.)
* Basic project management skills.
* Strong interpersonal skills, written, oral communication skills.
* Basic analytical and problem-solving capabilities.
* Demonstrated ability to work in cross-functional team environments.
* Computer literacy (MS Word, Excel).

Travel: 10%

Work From Home: No

Travel Percentage: None

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.