Job Description

Job Title Quality Engineer

Location(s) Chennai

Job Summary:

In this role, the Quality Engineer for the PKIG Laboratory will provide support to the Laboratory Director, Site Manager, and supervisors on all quality related matters both onsite in Chennai, India as well as at site in Europe and the United Kingdom. S/he will work with the Quality Manager to develop and implement training and education programs, to educate workers and management on quality processes, standards, and results. Assist in performing internal and external audits, maintaining proficiency testing records and quality metrics. S/he will participate in quality meetings with pertinent site management. A strong candidate for this position will be able to maintain good rapport and communication with leadership and team members while ensuring solid execution of all quality programs.

Duties and Responsibilities:

• Provide advice and support to the Quality Manager and testing personnel
• 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 local regulations.
• 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)
• 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

Required Qualifications:

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

Audit Experience:

• Minimum 6 years of experience in quality management or related clinical laboratory activities.

Required Work Experience:

• Should have prepared and faced NABL Assessors / CAP Inspectors.

Key Skills:

• 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.,

Training Requirements:

• 4 Days Training on ISO 15189:2012 from reputed organization / CAP Team Member Training preferred or required upon hire.

Preferred Qualifications:

• Experience with Quality Assurance, statistical Quality Control, and laboratory regulations/accreditation requirements required.
• Experience in a start-up / new business environment highly preferred.
• Previous experience of working in quality in clinical molecular biology or infectious disease 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
• Must have manual dexterity to use lab equipment
• Reach above/below the shoulder, bend at the knees and waist
• Able to lift boxes up to 25 pounds

Direct Reports: (indicate None or list the job titles that report into this role)

• None