Quality Control Manager
Pathshodh Healthcare Private LimitedSanjay Nagar, Bengaluru/Bangalore
₹90,000 - ₹1,25,000 monthly
Fixed
₹90,000 - ₹1,25,000
Earning Potential
₹1,25,000
Fixed
₹90,000 - ₹1,25,000
Earning Potential
₹1,25,000
Work from Office
Full Time
Min. 5 years
Good (Intermediate / Advanced) EnglishJob highlights
Urgently hiring
27 applicants
Benefits include: PF
Job Description
- Key Responsibilities
- 1. Quality Control Manager: Oversee sampling, inspection, and lot release testing for raw materials, biochemical reagents, electrochemical biosensors/test strips, and finished electronic diagnostic instruments.
- Analytical & Functional Validation: Define and execute test protocols for lot-to-lot repeatability, precision, linearity, analytical sensitivity, shelf-life stability (real-time and accelerated), and interference testing.
- Laboratory Integrity & Equipment: Maintain calibration, IQ/OQ/PQ, and qualification of analytical equipment (potentiostats, reagent dispensing systems, environmental chambers, optical/inspection tools) under Good Laboratory Practice (GLP).
- Investigation & CAPA: Lead root-cause investigations for Out of Specification (OOS), Out of Trend (OOT), non-conformances (NCR), and corrective/preventive actions (CAPA) across fabrication and assembly lines.
- 2. Regulatory Affairs (RA) & CE Marking (IVDR)CE Marking (EU IVDR 2017/746):
- Establish, compile, and maintain the IVDR Technical Documentation (Annex II & III) for handheld readers, firmware/software (SaMD/SiMD), and biosensor test strips.
- Oversee the Performance Evaluation Process (PEP), including the Performance Evaluation Plan, Scientific Validity Report (SVR), Analytical Performance Report (APR), Clinical Performance Report (CPR), and Post-Market Performance Follow-up (PMPF) Plan/Report.
- Serve as the primary technical liaison with EU Notified Bodies and the European Authorized Representative (EC REP); lead audit readiness, technical dossier reviews, and resolution of Notified Body queries.
- Coordinate with authorized labs and clinical partners to ensure compliance with European Common Specifications (CS) and harmonized standards.
- Domestic Regulatory Governance (CDSCO):
- Author, submit, and manage manufacturing licenses, test licenses, and import/export filings on the SUGAM / MD-Online portal under the Indian Medical Device Rules (MDR) 2017 (Forms MD-7, MD-9, MD-14, MD-15, etc.).
- Coordinate statutory performance evaluations with designated central testing laboratories (e.g., NIB, ICMR institutions).
- Quality Management System (QMS) & Audits:
- Direct and maintain compliance with ISO 13485:2016 and IVDR QMS requirements.
- Lead internal audit programs, host external Notified Body/CDSCO audits, and oversee Management Reviews.
- Post-Market Surveillance & Vigilance:
- Build and maintain the Post-Market Surveillance (PMS) system, generating periodic safety update reports (PSUR / PMS reports), vigilance filings, and managing Field Safety Corrective Actions (FSCA) if required.
- 3. Cross-Functional Leadership & TransferCollaborate closely with R&D, biosensing chemistry, instrumentation, software, and manufacturing teams to ensure Design Controls (ISO 13485 / Design Dossiers) and risk management (ISO 14971) align with CE and CDSCO requirements during design transfer.
- Supervise and mentor QC analysts and lab technicians, establishing robust standard operating procedures (SOPs).
- Qualifications & ExperienceEducation:
- Master’s or Bachelor’s degree in Biomedical Engineering, Biotechnology, Biochemistry, Analytical Chemistry, Pharmacy, or a related discipline.
- Experience:
- 5 to 10 years of progressive experience in Quality Control and Regulatory Affairs within the In-Vitro Diagnostics (IVD) or medical device industry.
- Proven track record with CE marking: Hands-on experience authoring or updating technical documentation under EU IVDR 2017/746 (or transitioning files from IVDD to IVDR) and direct interaction with European Notified Bodies (e.g., TÜV, BSI, DNV).
- Direct experience with CDSCO MDR 2017 regulatory submissions for Class B/Class C IVD devices.
- Direct experience managing ISO 13485:2016 certified quality systems.
- Technical Competencies & StandardsRegulatory Frameworks: EU IVDR 2017/746, Indian MDR 2017, ISO 13485:2016, ISO 14971:2019 (Risk Management), IEC 62304 (Medical Device Software Lifecycle), IEC 61010-2-101 (Safety requirements for IVD equipment), ISO 15197 (In vitro blood-glucose monitoring systems).
- Technical Writing: Comprehensive experience with IVDR Annex II/III dossiers, Device Master Records (DMR), Performance Evaluation Reports (PER), labeling, and Instructions for Use (IFU).
- Methodologies: Electrochemical biosensor testing (amperometry, cyclic voltammetry), lot release statistics, Gage R&R, and Statistical Process Control (SPC).
Job role
Work locationPathShodh Healthcare Private Limited, Doctor Rajgopal Road, Naidu Layout, Postal Colony, Sanjayanagara, Bengaluru, Karnataka, India
DepartmentOperations
Role / CategoryOperations Quality Control
Employment typeFull Time
ShiftDay Shift
Job requirements
ExperienceMin. 5 years
EducationGraduate
SkillsQuality Assurance/QA, FDA regulatory knowledge, Gmp, Regulatory affairs, Product registration
English levelGood (Intermediate / Advanced) English
GenderAny gender
About company
NamePathshodh Healthcare Private Limited
AddressPathShodh Healthcare Private Limited, Doctor Rajgopal Road, Naidu Layout, Postal Colony, Sanjayanagara, Bengaluru, Karnataka, India
Job posted by Pathshodh Healthcare Private Limited
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Work from OfficeFull TimeAny experienceNo English RequiredYou can expect a minimum salary of 90,000 INR and can go up to 1,25,000 INR. The salary offered will depend on your skills, experience and performance in the interview.
The candidate should have completed Graduate degree and people who have 5 to 31 years are eligible to apply for this job. You can apply for more jobs in Bengaluru to get hired quickly.
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