Stryker Senior Quality Engineer in Kalamazoo, Michigan
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.
What you will do
As a Senior Quality Engineer, you will be primarily responsible for the development and maintenance of the quality management system (QMS) in accordance with relevant regulatory requirements for medical devices. The Senior Quality Specialist will oversee and support that an effective and efficient quality management system is built and maintained. Has responsibility to ensure all necessary QS regulations are met in order to receive regulatory clearance/ certification.
Serve as SME on NC and CAPA process and electronic system(TrackWise).
Supports the Quality Management Systems compliance with the appropriate internal & external regulatory requirements, (including but not limited to European RHQ, Division, Corporate, FDA, ISO, MDD, and individual country regulatory requirements).
Contribute in developing optimum future state of QMS for business needs, aligned with Corporate, Divisional & SGS QMS.
Identifies improvements & inputs into the quality planning process.
Oversee and execute development and/or modification of Stryker's regional/local Quality Management Systems.
Co-ordinate Management Review and Quality Planning Review & Forums.
Assess & Quantify requirements for support of QMS to optimum structure under which the service required will be provided.
Drive GMP and GDP practices within Quality.
Identify and implement improvement opportunities to increase the efficiency and effectiveness of the Quality Management Systems.
Develop & deliver training/compliance for QMS group.
Contribute to the development, maintenance and improvements of the policies and procedures.
Implement best in class QS practices and benchmark against industry leads and regulatory requirements.
Liaise and communicate with notified bodies to manage certification changes.
Ensure QMS reflects actual activities and business needs and supports NPD requirements.
In a project environment, contribute to the development and/or modification of Stryker’s regional/local Quality Management Systems.
Proficiently take part in information systems discussions as required. Thinks about QMS from an IT perspective, including proficient contributions to SRS/URS activity.
Understands Quality Systems' & web-based interactions.
Proficiency in executing and leading projects, understands project stages.
proficient in improvement methods and processes.
Key contributor to the business process(es) and understands how IT system supports those business processes.
Supports the business during audits to discuss system functionality.
Has knowledge of the system integrations
Supports the Business Process Owner/QA approver in IT change control assessment and approval on behalf of the business, with understanding of change control requirements per regulatory and internal procedural requirements.
What you need
Bachelors Degree is required.
Minimum 2+ years experience working in quality, manufacturing, engineering or highly regulated environment.
Bachelors Degree in Engineering strongly preferred.
Experience interacting with regulatory agencies (FDA, MoH, TUV, etc.).
Knowledge and understanding of US and International Medical Device Regulations.
Strong knowledge of Quality Systems (e.g. CAPA, Audits, Management review, Quality Planning).
Strong communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously.
Demonstrated ability to successfully manage and complete projects in a matrix organization.
Demonstrated ability to work independently.
Experience in working in a compliance risk situation.
High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
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.
Stryker is one of the world’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 www.stryker.com
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