Program Manager, Regulatory Affairs/Quality Assurance
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
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
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
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
Manage and lead systems and personnel responsible for the
conduct of Stryker-operated value-added services within the US
Lead representative for Stryker for all regulatory and
third-party quality system audits (i.e. FDA, ISO, Supplier Quality,
Conduct audits in the role of Auditor, and as such, may produce
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
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
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
Provide input for Stryker Divisional, Group and/or Corporate
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
Demonstrate technical knowledge of medical device product lines
Demonstrated written, verbal, listening, communication, and
Demonstrated ability to collaborate effectively with and lead
Demonstrated ability to effectively prioritize and manage
multiple project workloads.
Demonstrated experience with trending and analysis
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
Prior QMS auditing experience in a regulated environment
Certified Lead auditor preferred.
High profile project management experience preferred.
Work From Home: OccasionalTravel 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. Posted Today
About Us 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