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Wipro is seeking SME?Team Lead  for our Medical Device Complaint Investigation teams who combine excellent leadership and complaint investigation skills with the ability to function effectively both as part of a team or on an individual basis to bring their talent to our team.

Wipro is a leading, publicly traded, global IT solutions and services company with over 230,000 dedicated employees serving clients across multiple continents and over sixty countries.

We offer a strong compensation package that includes competitive pay and day one benefits. Wipro also offers many opportunities for career advancement within our engaging and exciting culture.

Work Authorization – U S Citizen or U S Green Card only

Location – Work onsite - 2858 Woodcock Blvd (Davidson Building) Atlanta, GA 30341

Relocation - None

PRINCIPAL RESPONSIBILITIES:

• Direct oversight of day-to-day activities of the team
• Manages all required administrative tasks.
• Manages daily team attendance & shift roasters and team attrition.
• Ensures floor policies are followed.
• Responsible to safeguard productivity as per business requirements
• Identify defects to quality (CTQ), Trends, Top Defect Analysis (TDA)
• Support root cause analysis (RCA) and action plan for emerging/ongoing operational issues
• Provide coaching and feedback to production analysts
• Liaise with Philips counterparts on day-to-day operational activities
• Conducts a regular governance update (e.g., weekly reviews, monthly reviews)
• First Line of escalation for any issues, concerns and priorities on process and operational activities.
• Achieve target of all Performance and Quality performance indicators.
• May support training and qualification of new staff.
• Lead Team Huddles to ensure that all the client updates are shared with the team on a regular and timely basis.
• Keep abreast of changes in the process.
• Need to process Complaints as and when required
• To meet service level expectations and maintain high quality delivery.
• Has clear understanding of KPIs.

SKILLS REQUIRED:

• Understands CAPA, as well as global medical device regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, and ISO13485.
• Able to write effective Medical and Technical narratives regarding the complaints.
• Must have overall understanding & experience of medical device complaints handling process (Intake, Evaluation, Investigation, MDR reporting and Closure)
• Ability to perform efficiently under high pressure and in fast-paced settings
• Must have good understanding and hands on experience on MS-Excel (E.g. Pivot, Vlookup) and preparing PowerPoint presentations
• Good in stakeholder management
• Must have good computer skills.
• Able to think critically and ask pertinent questions to gather necessary information.
• Good problem solving and analytical skills.
• Attention to detail.
• Works autonomously within established procedures and practices to meet complaint timeline requirements.
• Able to handle a large team size of 20-30 people.

CANDIDATE SPECIFICATIONS:

• Bachelor’s degree
• Work onsite - 2858 Woodcock Blvd (Davidson Building) Atlanta, GA 30341
• Full Cycle Medical Device Complaint investigation with ClassI, Class II and/or Class III