Quality Engineer PMS
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Job Location:
Monthly Salary:
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Work Flexibility: HybridTravel Percentage: None
What you will do-
Perform preliminary complaint intake management and event classification.
Conduct customer follow-ups and assess complaints for regulatory reportabilityin accordance withFDA 21 CFR 803 EU MDR 2017/745 and ISO 13485.
Prepare and submit MDR MIR vigilance and global adverse event reports achieving zero late submissions.
Collaborate closely with stakeholders and team members providing guidance and coaching to drive engagement and performance.
Demonstrate strong knowledge of Post-Market Surveillance requirements (US FDA and EU MDR) Quality Management Systems (ISOCFR 820) and complaint handling tools such asTrackWiseor equivalent systems.
Experience withTrackWiseand Microsoft Project; Post Market Surveillance as per US FDA & EU MDR; Quality Management (ISO 13485 or 21 CFR 820 ; working with multiple teams and collaborating across geographically spread multi-functional teams.
Understanding on Medical Device Risk Management
What you will need-
Required-
BE/BTech/ME/MTech in Bio Medical / Mechanical Engineering / Electrical Engineering or related field from premier institutes
Experience- 2years to 5 years
1-2years of experience in Medical Device domain; At least1 years of experience in complaint handling or customer quality.
Preferred-
ISO 13485:2016certification
Strong analytical and problem-solving skills; excellent written and verbal communication skills and proficiencyin QMS software and tools.
Able toruncommunicate effectivelywith senior leadership.
Excellentproblem-solvingskills.
Proactive to support both internal and externalcustomers.
Required Experience:
IC
Key Skills
- APQP
- Quality Assurance
- Six Sigma
- ISO 9001
- PPAP
- Minitab
- Root cause Analysis
- ISO 13485
- Quality Systems
- Quality Management
- As9100
- Manufacturing
About Company
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. Alongsid ... View more
