Quality Assurance Engineer I

Job Description:

SUMMARY: Works on problems and projects of moderate scope where analysis of situation or data requires a review of identifiable factors. Participates in decisions on scope of work, selection of equipment and length of tasks. Decides on design changes to meet revised specifications. Provides and develops solutions to problems of limited scope. Must be able to accomplish broad assignments. May provide technical guidance to lower level personnel.

ESSENTIAL DUTIES AND RESPONSABILITIES include the following. Other duties may be assigned.

• Responsible for developing, applying, revising and maintaining quality standards for processing materials/products into partially or finished products.
• Helps design and implements methods and/or procedures for inspecting, testing and evaluating the precision and accuracy of products and/or production equipment.
• Analyzes reports and returned products and recommends corrective action.
• Respond to Supplier Correction Action Responses and determine if vendors need to receive SCARs.
• Prepares documentation for inspection/testing procedures.
• Plans and conducts work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures, and criteria.
• Devises new approaches to problems encountered.
• Respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
• Independently performs most assignments with instructions as to the general results expected.
• Receives technical guidance on low complexity problems and supervisory approval on proposed plans for projects.
• Plans, schedules, conducts, and coordinates detailed phases of engineering work in part of a major project or in a total project of small scope.
• Performs work which involves conventional engineering practice.
• Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
• Responsible for the purchase of equipment that meets health, safety and environmental standards set by the company.
• Responsible for performing design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes.
• May technically coordinate the work of technicians, and others who assist in specific assignments.
• Practices company safety, quality policies and procedures, actively requires conformance.
• May require conducting internal and supplier audits.
• Responding to complaints from customers and investigating the root cause.
• Migrate and integrate Quality Systems between transfer.
• Lead validation strategy for transfers.
• Support internal and external audits, war room others.
• Comply with all safety policies, practices and procedures. Report all unsafe activities to supervisor and/or Human Resources.
• Participate in proactive team efforts to achieve departmental and company goals.
• Perform other duties as assigned.

SUPERVISORY RESPONSIBILITIES:

Have supervisory responsibilities: No

Leadership: No

Supervises: N/A

Supervision:

General Direction: receive very general guidance with respect to overall objectives and work; operate within division or department policy guidelines using independent judgment in achieving assigned objectives.

EDUCATION and/or EXPERIENCE:

Basic:

• Bachelor´s degree in a related engineering discipline; 0-1 year of related experience.
• 1+ year of experience within medical device manufacturing industry performing quality engineering roles.
• Medium oral and written English level.

Preferred

• Experience in the medical device industry would be an asset.
• Certification and/or license in specific discipline would be an asset.
• Certified Quality Engineer would be an asset.
• Training as Internal Auditor in ISO 9001, 13485 or Biomedical field would be an asset.

OTHER SKILLS and ABILITIES:  

• Knowledge of precedents, principles and practices of related specialties would be an asset.
• Experience and knowledge in Process Validation in the Medical Device Industry would be an important asset.
• Knowledge of statistics and Minitab would be an asset.
• Customer service, quality focus, problem solving, market knowledge, documentation skills, confidentiality, analyzing information, multi-tasking, and project management skills.
• Ability to read, analyze, and interpret technical documents.
• Ability to write speeches and articles for publication that conforms to prescribed style and format.
• Ability to effectively present information to public groups among the natural working team.
• Ability to define problems, collects data, establishes facts, and draw valid conclusions.
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
• Proficient personal computer skills including electronic mail, record keeping, routine database activity, word processing, spreadsheet, graphics, etc.

MANUAL DEXTERITY: No special requirements.

VISION REQUIREMENTS: No special vision requirements

WORK SCHEDULE/HOURS: Monday – Friday.

TRAVEL: Minimal

ENVIRONMENTAL WORKING CONDITIONS

Well-lighted, heated and/or air-conditioned indoor office setting with adequate ventilation.

PHYSICAL DEMANDS

Other physical working conditions:     

Lifting or carrying items.

Moderate noise (examples: business office with computers and printers, light traffic)

PHYSICAL ACTIVITY LEVEL: Moderate physical activity moving around the manufacturing process and offices areas, as well as performing somewhat strenuous daily activities of a primarily administrative nature.

COMMENTS:  This position description is an outline of the major recurring responsibilities of the job. It is not intended to be all-inclusive of the work to be performed. The incumbent(s) will typically perform other related job objectives, special assignments and less significant responsibilities.