Head – Quality and Compliance

17 - 22 Years
Pune, Mumbai

Job Description

Job Objective
To be responsible for establishing a corporate quality assurance system and team that promotes customer satisfaction and that positively impacts the financial performance of the Group Companies. Champion strong technical documentation efforts and defect reduction initiatives to establish an effective Quality Management System (QMS).

Primary responsibilities
Strategic and planning
  • Derive the Quality functional strategy in line with the overall ACGE business strategy.
  • Formulate the Quality policy and Quality plan of the organization
  • Develop and cascade qualitative and quantitative metrics for quality
  • Set up global quality programs that support QMS requirements. Helps to lead and develop QMS requirements to ensure ownership, accountability, coordination and oversight across ACG globally.
  • Uses extensive expertise to improve the current approach to documentation
Functional
Quality Management

  • Design and drive Quality audit management programs at group level to ensure compliance with internal requirements and regulatory and compliance standards. Leads continuous process improvements to ensure non compliances are not repeated
  • Develop and propose deviation management strategy for global and/ or cross-functional implementation
  • Take high impact business calls such as product withdrawal, changes in warranty / guarantee policy etc,
  • Ability to set quality inspection strategy to prepare ACG Engineering for changing regulations, trends and enforcements activities
  • Initiates and implements quality improvement activities as appropriate (e.g., Kaizen, Six Sigma) to raise the performance of the companys product lines
  • Develops, implements, manages and integrates a QMS for manufacturing plants
  • Supports concurrent engineering efforts by participating in design development projects representing quality assurance and the customer
  • Establishes and implements metrics (process capability, control charts, measurement quality) for monitoring system effectiveness and to enable managers to make sound product quality decisions
  • Drives a culture of performing root-cause analysis and other problem solving activities to identify effective corrective actions and process improvements
  • Develops quality planning methods for all product lines
  • Develops process certification standards and assist in process certification
  • Monitors vendor performance and establish criteria and rating system for critical vendors
  • Supports NPD & Engineering in analysing customers product specifications to establish efficient, cost-effective requirements for ease of manufacture and reproducibility
  • Establishes collection and analysis systems of statistical data to predict trends that will affect improvement of product quality
  • Interacts with customers to identify opportunities to improve quality and establish feedback with manufacturing and development personnel
  • Oversees calibration and testing programs
Technical Documentation
  • Designs and implements documentation procedures for process control, process improvement, testing, inspection and qualification
  • Review the technical documents prepared by BU Quality and approve it
  • Reviews customer purchase orders, contracts and change requests and ensure that the necessary criteria and provisions are included in quality and process plans
Internal process
  • Prepare Quality budget manpower, equipment, testing cost, regulatory filing and get it approved from the Management
  • Developing the Quality Strategy, Annual Quality Plans and cascading those into concrete goals for all team members
  • Reports to management on quality issues, trends and losses
  • Participates in internal and external quality audits
  • Interfaces with supplier and customer quality representatives concerning problems with quality control and assure that effective corrective action is implemented
People development
  • Take overall responsibility for people development initiatives and building up in-house capabilities for the employees in the department
  • Drive a performance driven culture in the team by timely monitoring, review of performance parameters and feedback to the team members
  • Contribute towards development of talent for the department by providing subordinates with adequate exposure and growth opportunities to enable readiness for higher roles
  • Actively participate in HR initiatives to drive overall employee engagement and motivation
Key Result Areas
  • Number of quality issues
  • First Time Right
  • Cost of Poor Quality
  • Quality Certifications
  • NPS

Required Candidate profile

BE(Mech/Prod) with 17+yrs exp in Quality Assurance function of Engineering/Machine Building Industry, out of which atleast 5+years should be as Head of Corporate Quality function. Preference to those from Pharma/Medical or Biomedical machine manufacturing industry.
  • Cost control/budget management experience is a must
  • Knowledge of 21 CFR Part 820 and ISO 13485
  • Experience of managing inspections/audits by the FDA and other regulatory bodies
  • Working knowledge of quality tools such as SPC / Process Control, FMEA, Problem Solving / Root Cause Analysis, Poka-Yoke, and other Six Sigma tools
  • Six Sigma Certification preferred.

Perks and Benefits 

Excellent perks and facilities, 5 days week, Company Car, Mediclaim, Term Insurance, Accident Insurance, Retiral Benefits

Salary: Not Disclosed by Recruiter

Industry:Industrial Products / Heavy Machinery

Functional Area:Production, Manufacturing, Maintenance

Role Category:Senior Management

Role:Head/VP/GM-Quality Assurance/Quality Control

Keyskills

Desired Candidate Profile

Please refer to the Job description above

Education-

UG:B.Tech/B.E. - Electrical, Electronics/Telecommunication, Production/Industrial, Biomedical, Mechanical, Metallurgy

PG:M.Tech - Electrical, Electronics/Telecommunication, Production/Industrial, Biomedical, Mechanical, Metallurgy

Doctorate:Doctorate Not Required

Company Profile

Corporate Placement and Liaisoning Services

Indian MNC,3000+Crore turnover Group. Second largest in the world in product it manufactures. Leading manufacturer of Pharma machines. Has 17 mfgg plants in India and abroad and presence in more than 100 countries with its products and services.
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Contact Company:Corporate Placement and Liaisoning Services

Reference Id:CPLS_003