Job Description

PathnSitu Biotechnologies is a leading company in the supply of high-quality Immunohistochemistry products for tissue-based Cancer Diagnosis. We provide highly specific and sensitive Antibodies, Detection Kits, Histology Special Stains, Instruments, Reagents, Buffers, Antibody Diluents, Positively Charged Slides and all the Ancillaries required for Immunohistochemistry helping Pathologists and Cancer Research Laboratories with an accurate Histology-based Cancer Diagnosis.

The QA Manager - Medical Devices is responsible for establishing, maintaining, and improving the Quality Management System (QMS) in compliance with

ISO 13485, MDSAP, and applicable regulatory requirements

. The role ensures product quality, regulatory compliance, audit readiness, and continuous improvement across manufacturing and quality processes.

Key Responsibilities

Lead, maintain, and continuously improve the Quality Management System in compliance with

ISO 13485 and MDSAP

requirements Plan and manage

internal audits, external audits, and MDSAP audits

(FDA, Health Canada, TGA, ANVISA, PMDA, as applicable) Ensure compliance with applicable regulations including

21 CFR Part 820, EU MDR, and national regulatory requirements

Oversee

CAPA, Non-Conformance, Change Control, Risk Management, and Management Review

processes Review and approve quality documents including SOPs, protocols, validation reports, and quality records Ensure effective

supplier quality management

, vendor audits, and incoming quality control Lead investigations related to complaints, deviations, and product quality issues Support regulatory submissions and inspections in collaboration with RA teams Train and mentor QA team members on quality systems and regulatory compliance Drive continuous improvement initiatives and quality culture across the organization

Qualifications & Experience

Bachelor's or Master's degree in Engineering, Life Sciences, Biomedical, or related discipline

5-6 years of experience

in Quality Assurance within the medical device industry Strong hands-on experience with

ISO 13485 QMS implementation and maintenance

Direct exposure to MDSAP audits and readiness activities is mandatory

Experience working with global regulatory authorities is preferred

Key Skills & Competencies

In-depth knowledge of ISO 13485, MDSAP, and FDA QSR / EU MDR Strong audit management and inspection handling skills Excellent documentation, analytical, and problem-solving abilities Leadership and stakeholder management skills Ability to work independently and under regulatory pressure
Job Type: Full-time

Benefits:

Health insurance
Experience:

total work: 1 year (Preferred)
Work Location: In person