Principal Quality Systems Specialist

Location

Gurgaon | India

Job description

Careers that Change Lives

. QA team lead manage the day-to-day activities of QA team members, including scheduling and managing ongoing projects. Conduct employee training and evaluation and may provide support during the hiring and onboarding process. Oversee team members' work to ensure that they adhere to specifications.

. Supervise the over-all Quality Assurance - Shared Services Center team based in Manila for Asia Pacific Region - Japan and Korea on the following activities:

• Product Complaint Report Intake
• Complaint Determination including closure of Non-complaints
• Foreign Event Reporting Translations
• Request for any Add

• Utilizes problem-solving abilities to uncover problems within systems and to identify and suggest areas for improvements. Analyzes trends, develops and implements creative solutions, and completes projects as needed to ensure efficient operations and processes.
• Serves as lead to department employees including monitoring and assigning jobs and mentoring and training staff. Effectively coordinates team projects or department work groups.
• Setting goals for performance and deadlines covers the scope of Shared Services Center in ways that comply with company's plans and vision
• Organize workflow and ensure that each team members understand their duties & performance metrics
• Monitor each team member's productivity and provide constructive feedback and coaching
• Escalate on information from upper management to team members and vice versa

Key Accountabilities:

. Acts as escalation point for issues concerning the scope of QA Shared Services Center activities.

. Responsible in executing other duties that are assigned by APAC SSC Manager, SSC Subject Matter Experts, Program Manager &/or respective Country QA.

. Provide monthly reports for the Project scope of QA Shared Services Center activities to APAC SSC Manager.

. Support in achieving assigned goals and KPIs to meet quality requirements and objectives

. Prepare and submit performance reports

. Decide on reward and promotion based on performance

. Hire and train new employees

. Work within and actively promote Medtronic's Mission, corporate strategies, policies, procedures and Code of Conduct.

Attributes:

. Ability to learn a variety of job description

. Outstanding organization and leadership skills

. Excellent communication and interpersonal skill.

. Good written and spoken English ability

. Customer focused

. Good presentation and training skills

. Responsible, professional, detail-oriented and has patience

. Can work either autonomously or in a team

. Outgoing and friendly

. 'Can do' attitude

. Aptitude for technology

. Well organized, quick thinker, and creative

. Response to deadlines and priorities

. Resilient, persistent

. Welcomes and embraces changes well.

Must Have: Minimum Requirements

• At least 5 years of quality experience in medical device industry or similar environment
• Bachelor's degree in Science course or Engineering/ Quality Management or related discipline.
• Experience in handling/executing Field corrective action is an advantage.
• Computer literacy including sound knowledge of the MS Office Suite of software.
• Proven experience as supervisor or relevant role
• Good understanding of GDP and its implementation is required. Knowledge of ISO 13485 and its implementation will be an added advantage
• Sound working knowledge of ISO13485 is an advantage

Proven evidence of Medtronic Traits:

• - Mission Values : Consciously works to bring the Mission alive
• - External Focus : Customer responsive, competitive and market driven, leads and supports Change
• - Clear Thinking : Translates complexity into simplicity, articulates crisply and clearly
• - Driven to Win : Passionate and driven, makes tough decisions in difficult situations
• - Inspires Others : Authentic and sets a vision to inspire performance and engage others
• - Executes : Takes accountability for and consistently delivers consistent decisions, actions and results
• - Boundaryless : Breaks down silos, collaborates across organizational boundaries
• - Global : Culturally agile, strives to understand diverse market needs and responds with creative and effective solutions
• - Integrity and Compliance : Practice the highest ethical standards and integrity in every aspect of my job.

Job tags

Salary