Quality Engineer

Job Description

Additional Information

ESSENTIAL JOB DUTIES: 

Quality 

• Support colleagues in drafting and finalizing technical documents and the interpretation and application of legal, regulatory and project requirements 

• Quality management of orders in relation to: 

• Specific validation (DQ) 

• Validation documentation 

• Process controls 

• Work with technical team in the field as well as 3rd parties at customer sites to perform and successfully complete SAT, IQ, OQ, VPHP Cycle development and VPHP PQ activities. 

• Work with other colleagues to develop and maintain quality procedures and controls at Comecer Inc. facilities in North America to conform to customer and regulatory requirements. 

• Work with Comecer quality personnel and 3rd parties to establish regulatory approval for Comecer disposable kits for sale in North America 

• Develop inspection methods to analyze product quality 

• Implement a working system to ensure conformity and accuracy in the production process 

• Ensure products compliance with company and international quality standards 

• Ensure that the product corresponds to the desired technical specifications and take corrective action to resolve non-conformities 

• Plan and document control activities and inspections 

• Other duties as required.

Qualifications

QUALIFICATIONS: 

• Bachelor’s degree in technical field or equivalent experience.  

• Quality Engineering experience in a manufacturing environment preferred.  

• Experience with International Standardization Organization (ISO) standards 9001preferred. 

• Ability to communicate efficiently and effectively with people at all levels of the organization, both verbally and in written form.  

• Strong problem-solving ability. 

• Proficient in Microsoft Office suite. 

• Must be hands-on and must be able to meet deadlines for his or her responsibilities either directly or indirectly. 

JOB SPECIFICATIONS: 

• The employee may be required to stand, walk, push, pull, reach overhead, and bend to the floor. 

• Exert up to 50 pounds of force occasionally, and/or exert up to 10 pounds of force frequently.  

• Visual acuity – Normal requirements for reading written instructions and computer screens. 

• Hearing ability – Normal requirements for understanding verbal instructions.  

• Working conditions – The employee is subject to a normal office environment with occasional exposure to high noise levels and/or physical hazards when visiting the manufacturing floor.  

• Capable of wearing appropriate related PPE for extended periods of time.