Stryker RA/QA Manager in Plainfield, Indiana
Serve as site management representative and as a member of the Stryker Management with Executive Responsibility to the site’s Stryker Quality Management System (QMS).
Serve as the Official Correspondent to FDA, responsible for the annual registration of the establishment and the device listing. The official correspondent also receives correspondence from the FDA involving the owner/operator and any of the firm’s establishments.
Administer and manage all aspects of an effective Stryker QMS.
Manage and lead systems and personnel responsible for the conduct of Stryker-operated value-added services within the US CDC.
Lead representative for Stryker for all regulatory and third-party quality system audits (i.e. FDA, ISO, Supplier Quality, etc.).
Conduct audits in the role of Auditor, and as such, may produce audit reports.
Interact with on-site 3PL and Stryker Operations personnel to ensure 3PL process quality attributes are in compliance with Quality Management System (QMS) requirements, regulatory and state requirements, and Stryker Quality First initiatives.
Participate in the development and implementation of quality procedures, work instructions, and forms to coincide with operational and process related changes to daily work flow.
Liaise with on-site personnel to represent Stryker’s interests during Third Party audits of the 3PL.
Work with on-site personnel and Stryker personnel to ensure product hold/evaluation/release procedures are implemented; assure timely and accurate disposition of Stryker product including management of product damage, expiry, quarantine/holds, returned goods and recalls.
Liaise with Stryker Divisional representatives to coordinate standardization efforts in the receipt, inspection, and disposition of product; Resolve process quality related issues with Stryker Divisional representatives and trouble shoot quality related product and process issues that may arise.
Liaise with Stryker Divisions to ensure accurate communication of information to enable timely evaluation of nonconforming product.
Translate and set Stryker’s QA compliance strategy into quantifiable objectives and targets for the logistics environment; Identify and report on relevant performance indicators.
Participate in review and approval of site corrective action plans for product, process QMS audit, or Third Party corrective actions.
Cooperate with on-site personnel to implement quality strategies/systems and initiatives to improve work process compliance at the site level.
Ensure requirements and controls for newly transferred products are established within the Quality Management System.
Work with on-site personnel to implement Stryker training programs.
Provide input for Stryker Divisional, Group and/or Corporate Management Review.
Conduct industry benchmarking activities; identify and implement relevant continual improvement activities.
, Required Qualifications:
Bachelor's degree in applied science or engineering.
5+ years of relevant experience
Experience in a logistics environment a plus.
Experience implementing and managing Stryker Quality First programs, preferably in a logistics environment a plus.
Prior experience in developing, implementing, and managing process quality controls, design and development of training programs, lean documentation, and six sigma methodology.
Experience in a healthcare/medical device environment
Prior QMS auditing experience in a regulated environment a plus; CQA or Certified Lead auditor a plus.
High profile project management experience.
Strong organizational skills.
Strong organizational and written/verbal communication skills.
Self-motivated with the ability to effectively work with others in various coordinate disciplines and to prioritize tasks in a deadline-driven environment.
Willingness to travel when required.
Experience within Stryker Corporation in Manufacturing, Quality Assurance, and/or Field Operations a plus
• Five to ten years of experience in a healthcare/medical device environment"
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.
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