Quality Assurance Engineer, Staff

Job Description:

SUMMARY: Works on problem solving and improvement 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. Participates on design changes analysis to meet revised specifications during manufacturing. Provides and develops solutions to problems of limited scope. Must be able to accomplish broad assignments. Provides technical guidance to piers in the work team. Writes and runs manufacturing validation protocols, test method validations and software validation among others. Work on interdisciplinary teams. Works on interdisciplinary teams for manufacturing improvement or process transfer projects at site level as required.

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

• Applies and maintains quality standards for processing materials/products into partially or finished products.
• 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.
• Responds 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.
• Responds 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 moderate 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 moderate scope.
• Performs work which involves conventional engineering practice but may include a variety of complex features such as reducing sampling plans and using statistics to reduce the issues coming across.
• Ensures personal compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
• Selects the required equipment for the product Quality Assurance activities and ensures that such equipment meets health, safety and environmental standards set by the company.
• Acts as validation assessor for manufacturing processes under the area if expertise.
• Participates in validation efforts for process at sustaining stage or sound start-up of new processes.
• Develops validation protocols and reports for process and test method validation efforts and strategies.
• Approves validation documentation.
• Drives documentation and process changes.
• Technically supervises or coordinates the work of technicians and others who assist in specific assignments.
• Practices company safety, quality policies and procedures, actively requires conformance.
• Provides guidance on acceptance criteria of the manufacturing lines or on validation efforts for f the transferred product lines.
• Conducts internal audits and provides support to external audits.
• Responds to complaints from customers and investigating the root cause.
• Supports migration and integration of Quality Systems between transfer.
• Supports validation strategy for transfers.
• Comply with all safety policies, practices and procedures. Report all unsafe activities to supervisor and/or Human Resources.
• Participates in proactive team efforts to achieve departmental and company goals.
• Ensures non-conforming product is segregated and disposed as per internal procedures.
• Supports Risk Management plans (pfmea) development.
• Supports CAPA for process and Quality System improvement.
• Executes other activities designed by the Quality Manager as required.
• Supports team efforts to achieve departmental and company goals.

SUPERVISORY RESPONSIBILITIES:

Have supervisory responsibilities: Yes

Supervision: General Direction: receive very general guidance with respect to overall objectives; work is usually carried out in a teamwork environment with interdisciplinary internal and external teams; operate within division or department policy guidelines using independent judgment in achieving assigned objectives.

EDUCATION and/or EXPERIENCE:

• Bachelor degree in a related engineering discipline; 4-5 years of related experience combining a variety of manufacturing process, technologies and Quality Systems areas (i.e. but not limited to: Process Validation, Software Validation, Risk Management, Suppliers management, CAPA, Complaints, NCRs, Calibrations, Audits, Document Control, Quality Control, Quality Metrics and Change Control). Proficient oral and written English level.
• 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 ISO13485 would be an asset.

OTHER SKILLS and ABILITIES:

• Work requires a broad knowledge of precedents in the specialty area and a good knowledge of principles and practices of relates specialties. Experience and knowledge in Process Validation in the Medical Device Industry would be an important asset.
• Knowledge of basics statistics and Minitab is a must.
• Provides leadership to others through example and sharing of knowledge/skills.
• 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 common scientific and technical journals, financial reports, and legal 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, customers, regulatory members or business community.
• Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
• 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, ERP systems, etc.

MANUAL DEXTERITY: Manual dexterity sufficient to reach/handle items and work with the fingers.

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.