Program Manager, Regulatory Affairs/Quality Assurance in Plainfield, IN at Stryker Corporation

Date Posted: 7/24/2020

Job Snapshot

Job Description

Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a Program Manager, Regulatory Affairs/Quality Assurance to join our Group Quality Organization to be based in Plainfield, IN.

Who we want

  • Accuracy-oriented team leaders. Providing direct oversight of processes and results, managers who ensure accurate and timely completion of projections, forecasts or reporting. •
  • Subject matter experts. Managers who not only oversee the collection, review, and analysis of data but can interpret, translate, and present on all various matters as needed.
  • Network builders. Managers who build connections with other teams and divisions and coordinate cross-functional collaboration.
  • Compliance-focused orchestrators. Managers who carefully oversee people, processes, and deliverables to ensure compliance with company policies and procedures
  • Managers who drive performance. People who implement process improvements and leverage the talent of their team to consistently increase performance and productivity.
  • Quality-focused team drivers. People who push their team to deliver the highest quality products and solutions in a timely manner.
  • Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate. 
  • Data translators. Highly effective communicators who can transform data findings into recommendations to compose reports and executive level presentations. 
  • Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities. 
  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
  • Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues. 

What you will do

As the Program Manager, Regulatory Affairs/Quality Assurance, you will be responsible for the success of a Stryker multi-divisional & global distribution center run by a 3PL. You will be responsible for the quality and regulatory performance of: Inbound Operations (Unloading and Receiving), Warehouse Operations (Pick-Pack), Outbound Operations (Loading), Inventory Control, Transportation Operations (Carrier Relations), Loaner Kit Operations, Office Operations (Transportation Coordination and Customer Service) and Stryker value added services. You will work with the 3PL to implement objectives and be an on-site problem solver to maximize productivity, leverage expenses and drive the highest standards of quality and service. You will partner with the on-site Stryker Operations Manager to ensure cost, quality and service levels are being met.

  • 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.
  • Receive 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.

What you need

  • A minimum of Bachelor’s Degree required; preferably in Science, Engineering or related degree.
  • An advanced degree preferred.
  • A minimum of 9 years of experience in a highly regulated environment; preferably within quality and/or regulatory.
  • A Master's Degree or an advanced degree is preferred.
  • A RAC is desired.
  • Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and International requirements preferred.
  • Demonstrate technical knowledge of medical device product lines preferred.
  • Demonstrated written, verbal, listening, communication, and team-building skills.
  • Demonstrated ability to collaborate effectively with and lead cross-functional teams.
  • Demonstrated ability to effectively prioritize and manage multiple project workloads.
  • Demonstrated experience with trending and analysis reporting.
  • Demonstrated leadership skills.
  • Demonstrated process improvement and management skills.
  • Experience with recruiting and people development preferred.
  • Experience in a logistics environment preferred.
  • Prior experience in developing, implementing, and managing process quality controls, design and development of training programs, lean documentation, and six sigma methodology preferred.
  • Prior QMS auditing experience in a regulated environment preferred.
  • Certified Lead auditor preferred.
  • High profile project management experience preferred.

Work From Home: Occasional

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 contractor’s legal duty to furnish information.

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