Quality Engineer - Medical Device Complaint Handling

Stryker India Private Limited; Gurugram District; Ibrido; INR 600.000 - 1.000.000; Tempo pieno

Descrizione del lavoro

Stryker India Private Limited in Gurugram is seeking a Quality Engineer to review customer complaints, investigate product issues, and drive improvements in a hybrid work setup. You will collaborate with manufacturing, engineering, regulatory, and service teams to ensure timely, accurate records and robust solutions.

The role requires 2–4 years of quality management experience, proficiency with TrackWise, and knowledge of RCA, CAPA, and risk management.

Competenze

• Experience in Quality Management systems (ISO 13485 or 21 CFR 820) and complaint handling.
• Proficiency with TrackWise; strong RCA, CAPA, and risk assessment skills.
• Familiarity with BI tools and automation platforms for data-driven decisions.

Mansioni

• Review, assess, and process customer complaints per procedures and regulatory requirements.
• Conduct complaint investigations to identify failure modes, root causes, and product issues.
• Collaborate with manufacturing, engineering, R&D, regulatory, and service teams to resolve complaints.
• Ensure complaint records are complete, accurate, and closed on time.
• Support adverse event and vigilance assessments where applicable.
• Act as quality representative for complaint-related projects and initiatives.
• Provide guidance and training on complaint handling requirements and best practices.
• Partner with PM surveillance, regulatory affairs, and manufacturing to address quality concerns and drive improvements.

Conoscenze

Quality management

TrackWise

RCA

CAPA

Risk management

Power BI

UiPath

Automation tools

Formazione

BE/BTech/ME/MTech in Biomedical/Mechanical/Electrical Engineering

Strumenti

Power BI

UiPath

Descrizione del lavoro

Quality Engineer Work Flexibility: Hybrid

What you will do:

• Review, assess, and process customer complaints in accordance with established procedures and regulatory requirements.
• Conduct complaint investigations to determine failure modes, root causes, and product performance concerns.
• Collaborate with manufacturing, engineering, R&D, regulatory, and service teams to support complaint resolution.
• Ensure complaint records are complete, accurate, and closed within established timelines.
• Support adverse event and vigilance assessments where applicable.
• Act as a quality representative for complaint-related projects and initiatives.
• Provide guidance and training on complaint handling requirements and best practices.
• Partner with Post Market Surveillance, Regulatory Affairs, and Manufacturing teams to address quality concerns and drive product improvements.

What you Need:

• Required skills: Experience- 2 years- 4 years Experience on Quality Management (ISO 13485 or 21 CFR 820); TrackWise tool; Root Cause Analysis (RCA), CAPA, and risk management.
• Understanding on Medical Device Risk Management; New Product Development (NPD) Cycle Problem solving and decision making and project management experience and experience to lead & achieve global process improvement efforts.
• Basic knowledge of BI Tools and Automation tools. (e.g. Power BI, Ui Path, etc.)
• Preferred skills: BE/BTech/ME/MTech in Bio Medical / Mechanical Engineering / Electrical Engineering or related field from premier institutes
• At least 1+ years of experience in complaint handling or customer quality and 1 to 4 years of experience in Medical Device/Automotive/Manufacturing domain.

Travel Percentage: 10%

Experience Level Mid Level