Team Lead Complaint investigator

Wipro Technologies; Atlanta (GA); On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a skilled SME Team Lead for their Medical Device Complaint Investigation team. This role involves overseeing daily team activities, ensuring compliance with medical device regulations, and driving quality performance. The ideal candidate will possess strong leadership skills and a deep understanding of complaint handling processes. With a focus on continuous improvement, you will coach team members and manage stakeholder relationships. Join a dynamic organization that values innovation and offers a competitive compensation package, along with opportunities for career advancement in a supportive culture.

Benefits

Competitive pay

Day one benefits

Career advancement opportunities

Qualifications

• Strong understanding of global medical device regulations and CAPA.
• Experience with medical device complaint investigation processes.

Responsibilities

• Oversee day-to-day activities and manage team attendance.
• Conduct root cause analysis and provide coaching to analysts.
• Lead team huddles and ensure compliance with quality standards.

Skills

CAPA understanding

Medical device regulations

Medical complaints handling

MS-Excel proficiency

Stakeholder management

Problem-solving skills

Attention to detail

Team management

Education

Bachelor’s degree

Tools

MS-Excel

PowerPoint

Job description

Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO) is a leading technology services and consulting company focused on building innovative solutions that address clients’ most complex digital transformation needs. Leveraging our holistic portfolio of capabilities in consulting, design, engineering, and operations, we help clients realize their boldest ambitions and build future-ready, sustainable businesses. With over 230,000 employees and business partners across 65 countries, we deliver on the promise of helping our customers, colleagues, and communities thrive in an ever-changing world. For additional information, visit us at www.wipro.com.

We are continuing to grow! Come grow with us!!!

Wipro is seeking a 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 offers 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 rosters 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
• Conduct regular governance updates (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 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 the 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
• Full Cycle Medical Device Complaint investigation with Class I, Class II, and/or Class III

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We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, caste, creed, religion, gender, marital status, age, ethnic and national origin, gender identity, gender expression, sexual orientation, political orientation, disability status, protected veteran status, or any other characteristic protected by law.

Wipro is committed to creating an accessible, supportive, and inclusive workplace. Reasonable accommodation will be provided to all applicants including persons with disabilities, throughout the recruitment and selection process. Accommodations must be communicated in advance of the application, where possible, and will be reviewed on an individual basis. Wipro provides equal opportunities to all and values diversity.