Job Description

Why join Stryker?

Looking for a place that values your unique talents? Discover Stryker's award-winning culture.

We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards - not to mention various social and recreational activities, all of which are location specific.

Job description

We are excited to be named one of the World's Best Workplaces by Fortune Magazine!


We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards - not to mention various social and recreational activities, all of which are location specific.

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

Collaborative partners.

People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in function

Detail-oriented process improvers.

Critical thinkers who naturally see opportunities to develop and optimize work processes - finding ways to simplify, standardize and automate

Effective communicators

. People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and their teams.

Self-directed imitators.

People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

What you will do

Independently processing results of PFA assessments. Initiate, organize and coordinate global containment actions Ensure that data is documented for the different sites. Together with the PFA specialist create a communication to affected parties. Provide necessary information to regulatory compliance team for reporting. Presenting PFA/commercial hold relevant processes and cases during audits Preparing weekly, monthly and quarterly Commercial Hold relevant statistics Performing training of colleagues and managers by procedural changes

What you need

B. Tech / M.Tech Mechanical, Biotechnology with hands on experience of working on PFAs, and Commercial Holds. Hands on experience of problem-solving methodology and root cause analysis, 7 QC tools, Problem Solving & CAPA, Strong Analytical ability. Poses the ability to lead colleagues in other departments to perform the necessary actions for a timely Containment action Hands on experience of Risk Management process as per ISO 14971 Demonstrated ability to work effectively with various work groups to assure conformance to regulatory requirements, internal processes, and policies. Demonstrated ability to self-motivate, ability to prioritize tasks in a deadline-driven environment. Demonstrated ability to effectively work with others in various coordinate disciplines and on multi-national teams. Sound knowledge on complaint handling process of medical devices will be an added advantage Applied understanding of GDP, ISO 9001 & ISO 13485 (Good to have). Good understanding of FDA 21CFR Part 822 / 820 (Good to have)
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.