Stryker

Senior Quality Engineer - Complaints Handling

India · Work style not stated · Full time

You apply directly with the employer. ROLIVA does not submit applications from this page and is not the employer.

About the role

Description from the employer’s posting. Check the employer’s page for the current version.

Work Flexibility: Hybrid

Complaint handling and Product investigations of medical devices
Perform Visual, functional, dimensional, functional inspection & RCA of field returned products.
Maintain and ensure complaint files are complete and accurately reflect corresponding complaint activities.
Risk management –Risk assessment
Review of Process flow, DHR, Inspection plans, Measurement techniques, Review NC and CAPA and be able to identify any occurrence of an NC.
Review and analyze Literatures such as Clinical reports, PMCF reports, National register etc. to identify Complaints
Create PMS plan, PMS report, PSUR report as per EUMDR guidelines, Trend report & Complaint analysis.
Provide technical guidance and promote quality best practices across the organization.
Identify and lead opportunities for process improvement, redesign, and development of workflows.
Hold self and others accountable to deliver high quality results with passion, energy and drive to meet business priorities. Mentor, develop and inspire others in current and future roles.
Other tasks as assigned by manager.

Show full description

Required:

B. Tech / M.Tech Mechanical, Biotechnology with hands on experience of Complaint handling and product investigations process; problem-solving methodology, root cause analysis, 7 QC tools, Problem Solving & CAPA, Strong Analytical ability, and engineering drawing.
Hands on experience of Risk Management process as per ISO 14971.
Experience - 5years -7years
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).
Ability to collaborate and influence within matrix organizations and engage effectively with multiple stakeholders across multi-national teams.

Preferred:

Demonstrated ability to work effectively with various work groups to assure conformance to regulatory requirements, internal processes, and policies; 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 and mentor and lead a group of individuals towards meeting buisness needs and set them up for future success.

Travel Percentage: 20%

Check your resume against this job Free, no sign-up. Nothing you paste is stored.

Never pay to apply, interview or accept an offer. ROLIVA never asks you for payment to apply to a job.
Apply only through the official “Apply on the employer’s site” button, on the employer’s own site, and check that a recruiter’s email uses that employer’s own domain rather than a free email address.
Be cautious of an offer made with no real interview, or pressure to decide quickly or share financial details early.

Does something look wrong with this listing? Use “Report broken link” in the role details, or read ROLIVA’s full job-safety guidance ↗.

Check the fit.
Compare the requirements with the experience you have confirmed, including gaps.
Prepare honestly.
Build interview stories and application drafts from your own evidence.
Keep track.
Save the role and record your own application status and follow-ups.