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Summary
Develops, evaluates, revises, and applies technical quality assurance protocols/methods to inspect and test in-process raw materials, production equipment, and finished products. Ensures activities and items are in compliance with both company quality assurance standards and applicable government regulations. Performs analysis and identifies trends in the inspection of finished products, in-process materials and bulk raw materials, and recommends corrective actions when necessary. Ensures that established manufacturing inspection, sampling and statistical process control procedures are followed. May assure compliance to in-house and/or external specifications and standards, such as GMPs and ISO regulations. Evaluates and analyzes the efforts in organizing, documenting, and interpreting inspection support documents and records.
Job Description
Objective
- Manage, execute and maintain the calibration program of all Inspection, Monitoring and Testing Equipment (IMTE) / Monitoring and Measuring Devices (MMDs) in VCPH and VCPS entities
Position in the Organization
- Reports to the Assistant Quality Assurance Manager (VCPH/VCPS/VCCN)
Main Duties
- Establishes, implements, and maintain the Calibration program for all IMTE / MMDs used in VCPH and VCPS
- Ensures all IMTE / MMDs are maintained and calibrated as scheduled and acceptable GRR studies maintained
- Performs internal calibration and verification on IMTE / MMDs
- Liaises with Procurement and External Calibration Service Providers
- Propose Calibration budget and monitors budget usage
- Ensures all calibration records are complete as required and kept on file
Responsibilities
- Assist in ensuring that the quality management system for VCPH comply with the Global C&C Quality Management System and with the applicable International Requirements, including, but not limited to, ISO9001, ISO13485, MDSAP, EU MDR/MDR, FDA CFR, Health Canada
- Support the VCPH, VCPS Organization on achieving high quality goal and on quality continuous improvement initiatives
- Manage the Calibration of IMTEs used in VCPH and VCPS
- Reports to the Assistant QA Manager (VCPH_VCPS and VCCN) the quality status, progress and results of work
Authorities
- In authority to carry out all activities needed in maintaining and implementing VCPH Quality Management System
- In authority to retrieve IMTE for calibration and confiscate IMTE with overdue / expired calibration
Background
- Engineering graduate. Preferably mechanical, electronics & communications, electrical or metallurgical engineer
- At least five years of work experience in a manufacturing environment as a Calibration Engineer preferably with ISO 9001 experience. Experience in ISO 13485 and ISO 17025 is an advantage
- At least 5 years work experience as an Internal Auditor in an ISO 9001 manufacturing setting. Internal Auditing experience in an ISO 13485 manufacturing setting is an advantage
- Process-oriented and a self-starter with the ability to quickly learn new processes
- Ability to work on own initiative and can work with least supervision
Skills
- Computer literate: MS Office programs (Word, Excel, Power Point and Outlook)
- Intensive skills and technical competencies in different IMTEs / MMDs Calibration
- Strong problem-solving skills
- Good oral and written communication skills
Time Type:
Full time
Job Type:
Regular
Work Shift:
N/A
Pay Rate Type:
Salary
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.