QC Engineer

Quality Engineers work with manufacturing, engineering, R&D.

QC Engineer

Xtruline transforms a large variety of thermoplastic polymers. Xtruline applies diverse extrusion techniques, which capacitate the production of tubes used in the manufacturing of medical devices.

We are now seeking for our QC Engineer who will Team up with the Xtruline Team.

This role ensure the overall quality of in-prcoess quality checks. It monitors quality of each lots of products for adherence to company, regulatory standards and best practices. The quality engineer play a key role in fixing issues when a non-conformace arise. It also involves in creating/updating necessary QMS documentation as required.

The goal is to detect defective products before they’re shipped to the end user. When customers receive quality products, Xtruline Co Ltd shall maintain or improve his position in the market, get new customers from referrals and increase loyalty.

The job incumbent will be mainly required to:

• Planing and work allocation of Incoming/Final quality testing.
• Monitors quality of each lot of products for adherence to company and regulatory standards.
• Review test report, DHR records and prepare product release documentation.
• Escalation of quality issues as appropriate.
• Initate non-conformace, conduct investigation, bounding, documentation, review of non-conformances.
• Track all non-conformance reports, material review board (MRB).
• Work with cross functional department to support root cause analysis activities, corrective action plan and effectiveness monitoring of NCs.
• Supports the manufacturing line to address quality issues and resolution.
• Collaborates with other department such as engineering, manufacturing, regulatory to ensure quality standards are in place.
• Participates in quality improvement initiatives and projects.
• Developing good working relationships within the department.
• Develop strong and effective working relationships with the Production team, regulatory, R&D to ensure efficient and effective processes.
• Have clear and good communication with all deparments.
• Provides Quality Manager with regular updates on all activities.
• Fosters good teamwork.
• Liaise with Human Resources for new man power recruitment and/or replacement.
• Evaluate employees during the dialogue process.

• Work in collaboration with Human Resources department to design and develop training program either external or internal training.

• Training quality control inspectors to their function and ensure that they get the training needed in relevant areas to do their job well.

• Adheres to company policies and standards.
• Update any existing QMS documents such as WI, QSP, TM, Print.
• Create new QMS documents in case of new products or new requirements.

Qualifications & Certifications

• A minimum of a Bachelor Degree, preferably in Engineering or related technical field.
• Technical training and experience using Statistics, Lean and Six Sigma Methodologies etc.

Experience

• About 1 to 2 years of experience Quality control department from Medical device background or
• 2 to 3 years of quality control experience from other industry field.
• Working knowledge of quality system requirements
• Experience with MS Word, Excel, Project Management, and Analytics software

Skills & Attributes

• Knowledge of applicable product specific standard such as ISO 10555, PTCA special control guidance, ISO 25539.
• Understanding of FDA, ISO 13485, CE and GMP requirements, with the ability to interpret these requirements and implement them.
• Proficiency in quality control tools such as Fishbone, Pareto, 5-why, Control chart, Histogram and statistical techniques, minitab etc
• Good problem-solving mindset
• Demonstrate strong leadership skills, communication skills and promote quality at source
• Ability to set and deliver to specific goals and targets.
• Strong computer skills, Excel, Word, PowerPoint
• Perform production work on plastic extrusion and compounding equipment for the Xtruline facility.
• Ensure the quality of the products within the framework of the standards in force at the Compagny.
• Ensure the maintenance of Technical production facilities.
• Maintain the quality of the environment and the means of production used (machinery and tools).
• Use the techniques of micro assemblies in the field of mechanical and plastics.
• Participate in inventory.
• Participate in the development of protocols and reports validation (IQ / OQ / PQ).

Qualifications and Experiences:

• Diploma in Electromecanics or relevant engineering field.
• Mechanical aptitude with 1 year of experience in manufacturing or mechanical environment. (Training in house will be given).
• Communicate problems or issues verbally and written in English and French.
• Read and understand procedures, safety sheets, instructions and policies.
• Work with measuring devices.
• Follow proccesses and advanced understanding of the technical job duties.
• Conduct basic arithmetic calculations (add, subtract, multiply and divide).
• Perform simple calculations using a calculator.
• Basics of CAD.

Benefits:

• Training plans
• Medical Insurance
• Team Building
• Transport

We invite you to join us and reach the opportunity to work in an International Company with a friendly work environment. With the possibility to learn and grow in Competences.

‘Our Mission is to save lives everyday’.

We thank you for your interest in this job offer.