Laboratory Quality Manager

Job Title: Senior Laboratory Quality Manager
Location: Nasik
Position Type: Full-Time

Job Summary:

We are seeking a highly motivated and experienced Senior Quality Manager to lead and oversee our quality assurance and control initiatives. You will be responsible for developing and implementing robust quality management systems, ensuring compliance with regulatory standards, and driving continuous improvement across all operational areas, specifically adhering to ISO 13485, ISO 14971, ISO 27001, ISO 15189, and CLIA requirements.

Work Environment:

The role is based in a high-paced diagnostic laboratory environment where precision, adherence to protocols, and attention to detail are paramount. The position may require occasional lifting, prolonged standing, and adherence to laboratory safety protocols, including the use of personal protective equipment (PPE).

Key Responsibilities:

Quality Management System (QMS): Develop, implement, and maintain a comprehensive QMS that aligns with ISO 13485 and ISO 15189 standards, ensuring compliance with CLIA regulations.

Risk Management: Conduct thorough risk assessments and implement risk mitigation strategies in accordance with ISO 14971.

Information Security: Oversee information security practices to safeguard sensitive patient data, complying with ISO 27001 standards.

Quality Assurance: Oversee quality assurance activities, including inspections, testing, and audits to ensure product and process conformity, aligning with ISO 13485 and ISO 15189.

Quality Control: Lead quality control efforts to identify and mitigate quality issues, reduce defects, and enhance product quality, adhering to ISO 13485 and ISO 15189.

Regulatory Compliance: Ensure adherence to relevant regulatory standards, such as USFDA, EU MDR, and CLIA.

Continuous Improvement: Drive continuous improvement initiatives, such as Lean Six Sigma, to optimize processes, reduce costs, and enhance efficiency, while maintaining compliance with ISO 13485 and ISO 15189.

Team Leadership: Lead and mentor a team of quality professionals, providing guidance, training, and performance management.

Stakeholder Management: Collaborate with cross-functional teams, including engineering, manufacturing, and supply chain, to ensure quality objectives are met, aligning with ISO 13485 and ISO 15189.

Reporting and Analysis: Generate regular quality reports and analyze key performance indicators (KPIs) to identify trends and inform decision-making, complying with ISO 13485 and ISO 15189.

Qualifications:

a) Master's degree in science, or a related field.

b) 10+ years of experience in quality management roles in a healthcare or medical device industry, with a strong understanding of ISO 13485, ISO 14971, ISO 27001, ISO 15189, and CLIA requirements.

c) Proven track record in implementing and managing quality systems, especially in regulated environments.

d) Strong understanding of quality methodologies, tools, and techniques, including risk management, CAPA, and corrective actions.

e) Excellent problem-solving and analytical skills.

f) Strong leadership and interpersonal skills.

g) Ability to work effectively in a fast-paced, dynamic environment.

h) Proficiency in relevant quality management software, such as QMS software and statistical analysis tools.

i) Certified Quality Auditor (CQA) certification is preferred.

Work Environment:

The role is based in a high-paced diagnostic laboratory environment where precision, adherence to protocols, and attention to detail are paramount.

Why Join Us?

We offer a dynamic and supportive work environment, with opportunities for professional growth and development. Joining our team means you will play a vital role in enhancing patient care by ensuring the quality and accuracy of diagnostic testing that supports critical healthcare decisions.

Datar Cancer Genetics is an equal-opportunity employer committed to diversity and inclusion. We encourage applicants from all backgrounds to apply.

Job Types: Full-time, Permanent

Schedule:

• Day shift

Work Location: In person