Quality Systems Specialist-Mumbai

2+ years

Not Disclosed

Mumbai

10 Aug. 6, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Embark on a Career of Innovation and Healthcare Advocacy at Medtronic

At Medtronic, begin a life-long journey of exploration and innovation while championing healthcare access and equity for all. Lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

Responsibilities include:

Serve as the subject matter expert for the supplier management process.
Support users with supplier selection, evaluation, and segmentation per Medtronic's supplier management procedures, and maintain related supplier files in the document management system.
Manage and maintain the Approved Supplier List (ASL) in the document management system.
Provide updates to leaders, stakeholders, or partners responsible for supplier approval.
Prepare, update, and monitor audit/performance evaluation schedules for supplier management processes.
Investigate poor supplier performance ratings, identify causes, and work with suppliers to implement improvements.
Effectively identify root causes and coordinate with suppliers to ensure corrective and preventive actions through the Supplier Corrective Action and Preventive Action (CAPA) process.
Provide guidance for supplier change requests, including communication, project management, and regular reporting.
Offer analytical support for key metrics and periodic reporting to update internal stakeholders on the status of supplier management (e.g., number of new suppliers, supplier changes, SCAPA incidents).
Manage relationships with external suppliers to represent Medtronic effectively, deliver best value, and provide a competitive advantage.
Train and mentor suppliers as needed.
Ensure suppliers meet obligations agreed upon by contract.
Understand and follow all quality policy/system items applicable to the role, ensuring quality system compliance and high-quality work.
Operate within compliant quality system environments.
Participate in and support internal and external Supplier and Quality System Audits in supported regions.
Act as a change agent for the organization, identifying, facilitating, and implementing changes to improve efficiency, compliance, and process simplicity.
Leverage business-specific tools and systems used throughout Operations at Medtronic for optimal decision-making.
Use the ERP system (SAP) to conduct duties and generate metrics.
Demonstrate proficiency in applicable software tools such as MS Excel and Business Object.
Support drafting and execution of pertinent written agreements/documents for ongoing requirements, such as purchase orders and Memoranda of Agreement.
Understand the implications of different types of commercial agreements and choose the appropriate agreement for the circumstances.

Specialist Career Stream

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and manages projects and works with stakeholders to achieve desired results. May mentor colleagues or direct the work of lower-level professionals. Most of the time is spent on project delivery and oversight, adhering to policies and using specialized knowledge and skills normally acquired through advanced education.

Differentiating Factors:

Autonomy: Works independently with general supervision on larger, moderately complex projects/assignments.
Organizational Impact: Sets objectives for own job area to meet project and assignment goals. Contributes to project milestones and may be involved in cross-functional assignments.
Innovation and Complexity: Faces general problems and issues that may require understanding broader issues or job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness.
Communication and Influence: Communicates primarily with internal contacts. External interactions are less complex and problem-solving in nature. Shares information, status, needs, and issues to inform, gain input, and support decision-making.
Leadership and Talent Management: May provide guidance and assistance to entry-level professionals and/or employees in the Support Career Stream.

Required Knowledge and Experience

Bachelor’s degree required.
Minimum of 2 years of relevant experience in engineering and/or quality experience in the medical industry or related field, or advanced degree with 0 years of experience.
Dynamic team player who can work effectively and proactively on cross-functional teams.
Good communicator, fluent in English (both verbal and written).
Evening shift availability.
Certified Quality Auditor certification.
Previous experience supporting quality system audits.
Strong technical writing and documentation review skills.
Strong critical thinking and analytical skills.
Independent compliance decision maker based on knowledge of regulations, available relevant information, and alternatives.
Good understanding of Medical Device Regulations and the Food and Drugs Acts as pertinent to the position.
Working knowledge of ISO 13485, and Medical Devices regulations/guidance on the Control of Products and Services obtained from Suppliers.
Good understanding of FDA regulations for Medical Devices and Drugs regarding Complaint Handling/Mandatory Medical Devices Problem Reporting, Adverse Events reporting, and Recalls.
Certified Quality Engineer, Reliability Engineer, or equivalent desired.
Influence management skills; ability to work constructively across all functions of the organization and build relationships.
Experience in writing and reviewing technical documentation.

Physical Job Requirements

Independently mobile and able to interact with a computer and communicate with peers and co-workers.
Ability to travel up to 50% of the time.

Benefits & Compensation

Medtronic offers a competitive salary and flexible benefits package. We value our employees and recognize their contributions, sharing in the success they help create. Our benefits, resources, and competitive compensation plans are designed to support you at every stage of your career and life.

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

About Medtronic

We lead global healthcare technology, boldly addressing the most challenging health problems by finding innovative solutions. Our mission — to alleviate pain, restore health, and extend life — unites a global team of over 90,000 passionate individuals. As engineers at heart, we turn ambitious ideas into real solutions for real people, from the R&D lab to the factory floor to the conference room. With diverse perspectives and a fearless approach, we engineer the extraordinary.

Learn more about our business, mission, and commitment to diversity here.

Medtronic is an equal opportunity employer committed to fostering an inclusive and diverse workplace.