Quality Assurance Principal

The Quality Assurance Principal is responsible for supporting DeepHealth products and product development and for Quality Management System effectiveness across the organization. This individual contributor role leads design-quality and product lifecycle quality work owns assigned QMS processes such as CAPA and complaint management guides junior Quality Assurance team members and partners with Engineering Clinical Marketing and QRC colleagues to maintain compliance with applicable US and outside-US standards and regulations.

Essential Duties and Responsibilities

• Engage cross-functionally with Engineering Clinical Marketing and other partners to support new product development through Product Lifecycle Management (PLM) and New Product Introduction (NPI) processes.

• Act as the Quality lead for design changes to existing DeepHealth products including non-medical devices so changes remain compliant with applicable standards and guidance.

• Guide junior Quality Assurance team members on consistent implementation of quality processes including design control and risk management.

• Own assigned product-related Quality Management System processes such as CAPA and complaint management to maintain compliance and improve efficiency.

• Work cross-functionally to integrate products following corporate and/or product acquisitions.

• Partner with the Quality Assurance team to maintain compliance with applicable US and outside-US standards and regulations.

• Support preparation for and participation in regulatory audits related to design quality and QMS processes as assigned.

• Collect and monitor quality metrics in support of Management Review.

• Identify quality and compliance risks escalate issues that may affect patient safety or market compliance and drive corrective and preventive actions to closure.

• Contribute to continuous improvement of design quality and QMS processes and support development of junior staff as requested.

PLEASE NOTE: This is not an exhaustive list of all duties responsibilities and requirements of the position described above. Other functions may be assigned and management retains the right to add or change duties at any time.

Minimum Qualifications Education and Experience

• Bachelors degree in a relevant field or equivalent practical experience (for example an Associates degree with 5 years of related experience) (required).

• 8 to 10 years of experience in a regulated industry (required); FDA-regulated and Software as a Medical Device experience preferred.

• Strong knowledge of FDA Quality System Regulations including 21 CFR Part 11 and 21 CFR Part 820 (required).

• Demonstrated experience leading design quality design control and/or QMS process ownership in a medical device or SaMD environment (required).

• Experience guiding or mentoring junior Quality Assurance colleagues without formal people management (required).

• Excellent written and oral communication skills (required).

• Preferred: Knowledge of EU MDR ISO 13485 ISO 14971 and IEC 62304.

• Preferred: Knowledge of pre- and post-market clinical study requirements (for example 21 CFR Parts 812 50 and 56).

• Preferred: Participation in regulatory audits.

• Preferred: Experience supporting product or quality integration following acquisitions.

Quality Standards

• Communicates cooperates and consistently functions professionally and harmoniously with all levels of supervision co-workers visitors and vendors.

• Demonstrates initiative personal awareness professionalism and integrity and exercises confidentiality in all areas of performance.

• Follows all local regional and country laws concerning employment.

• Follows all DeepHealth policies and procedures.

• Follows data privacy compliance safety and confidentiality standards at all times.

• Practices universal safety precautions.

• Promotes good public relations on the phone and in person.

• Adapts and is willing to learn new tasks methods and systems.

• Reports to work regularly as scheduled; consistently punctual with respect to working hours meal and rest breaks and maintains satisfactory personal attendance in accordance with DeepHealth guidelines.

• Completes job responsibilities in a quality and timely manner.

Travel

This position may require occasional travel for audits acquisitions support or cross-site collaboration.

Working Environment

Remote / Hybrid. India (per requisition). Flexible schedule may be required to support international teams.

Physical Demands

The employee must be able to perform the essential duties and responsibilities of the position with or without reasonable accommodation.

Salary:

Based on experience:

3050 LPA (INR annual)