Senior Manager, Quality and Regulatory- IIC

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers. 

Are you looking for an inspiring career? You just found it.

Job Overview
Head of Quality and Regulatory Compliance is responsible for leading the Quality and Compliance Groups
for the India Innovation Center (IIC) in Bangalore, India. The position will be required to participate on the
leadership team of Getinge India. This position is responsible for directing the quality assurance functions,
ensuring the effective establishment and maintenance of quality systems in the projects executed at IIC.

Job Responsibilities and Essential Duties

• Provide strategic leadership and management for the Quality Systems for the IIC.
• Develop a competent and accountable Quality organization that is positioned to support and
  accomplish business objectives while maintaining compliance with applicable standards, laws and
  guidance.
• Has established responsibility and authority for the following:
  • Building up a quality management system and imbibe quality culture at
    IIC.
  • Ensuring that the quality management system is effectively defined,
    documented, implemented, and maintained.
  • Reporting to top management on the performance of the quality management
    system.
  • Authority to act on behalf of top management during audits (internal and external)
  • Authority to place products or processes on hold.
  • Managing quality audit functions.
  • Contributing to corrective and preventive action activities, handling of
    nonconformance product.
  • Implementing ISO13485 and MDSAP in addition to QSR.
  • Stakeholder Management and the ability to lead the change ( high importance need)
  • Startup mindset, where person should be able to work on the ground at the initial phase while working on the future development of the quality organization. Past
    experience similar to this will be advantage.
  • Responsible for assuring the business functions operate in compliance with applicable domestic &
    international requirements, laws and guidance. Drive and implement new Quality System structure
    for IIC.
    
    • Perform the role of divisional (CS/VI) Management Representative.
    
    • Oversee third party quality systems inspections and audits, (i.e. FDA, ISO, Corp, etc.).
    
    • Oversee preparation of third-party audit responses.
    
    • Work with cross functional teams to ensure that quality metrics that align to the corporate goals are met.
    
    • Establish credibility and confidence with key internal and external colleagues through regular communication and proven performance.
    
    • Support a Quality program which instills personal accountability for accuracy, consistency, and completeness for all departments.
    
    • Work with cross functional teams to effectively create and support process and quality enhancement initiatives to create and maintain an environment of excellence and continuous improvement.
    
    • Manage departmental costs and spending in support of business objectives.

Minimum Requirements

• Bachelor's degree in engineering or Life Science related field or equivalent.
• A minimum of 15 years hands-on experience in Quality Assurance, preferably in a medical device company.
• Able to work ground up to build the quality system in the R&D organization to match and surpass global requirements and customer expectations.
• Startup mindset, where person should be able to work on the ground at the initial phase while working on the future development of the quality organization. Experience similar to this will be an added advantage.
• Progressive leadership experience including hands on advanced quality system strategy.
• Excellent knowledge of FDA and EU regulatory compliance for medical devices.
• Demonstrated knowledge of Quality System Regulation (QSR) and Quality System Inspection
  Technique Audits (QSIT).
• Strong influencing skills and the ability to build strong interpersonal relationships.
• Excellent communication skills including public speaking and strong written skills.
• Demonstrated leadership in a cross-functional environment.
• Advanced skills in MS Office applications (Word/Excel) are required.

Required Knowledge, Skills, and Abilities
Leadership Competencies:

• Communication – Demonstrated ability to communicate effectively oral and written form at executive level.

• Interpersonal – Ability to develop and sustain positive relationships with internal as well as external customers.

• Managerial – Coach, develop and motivate associates to optimize team effectiveness and enhance team interactions.

Supervision/Management of Others

• Responsible for the development and management of employees in the Quality Organization.

• Oversee utilization of external contractors from skill sets and cost perspective.

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About us 

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.