Senior Quality Engineer

revvity

Chennai, India

6-8 Years

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Posted 4 days ago
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Job Description

Main Responsibilities

Provide advice and support to the Quality Manager and testing personnel on quality issues.
Assist in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements
Understand the Document Control System (PolicyTech) to ensure SOPs, Trainings and Policies are current versions and assigned appropriately. Notify Department leaders of employee signoffs not completed within deadlines.
Assist in the review of all SOPs, validations, and incident reports to ensure they meet Quality standards and adhere to company guidelines.
Participate in the maintenance of laboratory licensure as required by CAP, ISO and NABL.
Review quality assurance and control of laboratory performance through internal and external audits
Training & Education: Assist with training and education programs, to educate employees and management on quality processes, standards, and results
Project Management: Participate in the planning, initiation, and management of quality improvement projects
Lead and implement various product and process improvement methodologies (e.g., Six Sigma)
Lead risk assessments for all areas of laboratory activities
Maintain good communication with leadership, team members and customers
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Understand ergonomic relationship between people, equipment and working environment.
Familiarity with operation of laboratory instruments and applicable computer software.
Other duties as assigned

Qualifications:

M.Sc., / B.Sc., Biochemistry / Genetics / Microbiology / Medical Laboratory Technology (MLT) or related disciplines.

Required Work Experience Related To Position –

Minimum 6 years of experience in quality management or related clinical laboratory activities.
Should have prepared and faced NABL Assessors / CAP Inspectors.
Must be able to assess the need for, handle and implement Quality Improvement initiatives Independently, Prepare Quality Metrics, Report Management results of Improvements, Conduct Internal Audits, Face External Audits, Prepare Reporting, Documentation, SOP preparation, Change Control, etc
4 Days Training on ISO 15189:2022 from reputed organization / CAP Team Member Training preferred or required upon hire.
Experience with Quality Assurance, statistical Quality Control, and laboratory regulations/accreditation requirements required.
Experience in a start-up / scope expansion / new regulations / new business environment highly preferred.
Previous experience of working in quality in clinical molecular biology or biochemical genetics testing labs as a Lab Technologist
Knowledge of CAP regulations and familiar with local regulations
Partner and work collaboratively with laboratory operations staff
Proven track record of delivering continual positive process improvement in systems and process.
Proven leadership and excellent organization and communication skills
A good balance of negotiating and influencing skills.
Excellent presentation skills
Be detail oriented, organized, with excellent verbal and written communication skills.
Able to work effectively and able to deliver on tight datelines
Comfortable working in a fast-paced environment

Working Conditions: (describe office, lab environment, include shifts and any travel)

Clinical and research lab environment; exposure to blood borne pathogens; must wear personal protective equipment including lab coat, gloves and completely closed footwear while in the Laboratory.
Travel to other sites may be required.

Physical Requirements:

While performing the duties of this job, the employee is regularly required to sit, stand, use a keyboard, type, and occasionally stand and move to other parts of the lab
Reach above/below the shoulder, bend at the knees and waist.
Able to lift boxes up to 25 pounds