Quality Assurance Engineer, Senior Staff

Job Description:

Works and leads on problem solving and improvement projects of extend 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. Analyzes design changes to meet revised specifications during manufacturing. Provides and develops solutions to problems of moderate to complex scope. Must be able to accomplish broad assignments. Provides technical guidance to the company. Must be able to write and run manufacturing validation protocols, test method validations and software validation among others. Work on interdisciplinary teams for manufacturing improvement or process transfer projects from different sites as required.

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

• Develops, applies, revises and maintains quality standards for processing materials/products into partially or finished products.
• Designs 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.
• 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 unusual or complex 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 to complex 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 and company 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 multiple manufacturing processes under the areas of expertise.
• Participates in design reviews and validation efforts for processes 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 engineers, draftspersons, technicians, and others who assist in specific assignments.
• Practices company safety, quality policies and procedures, actively requires conformance.
• Aligns criteria on the manufacturing lines and on validation efforts for f the transferred product lines.
• Conducts internal and supplier audits as required.
• Responds to complaints from customers and investigating the root cause.
• Ensures non-conforming product is segregated and disposed as per internal procedures.
• Leads Risk Management plans (pfmea) development.
• Leads and conducts CAPA for process and Quality System improvement.
• Acts as Quality Manager as required.
• Executes other activities designed by the Quality Manager as required.
• Leads team efforts to achieve departmental and company goals.

EDUCATION and/or EXPERIENCE: Bachelor degree in a related engineering discipline and 6-7 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). Certified Quality Engineer. Proficient oral and written English level. Experience in the medical device industry would be an asset. Certification in Black Belt would be an asset. Experience as Internal Auditor in ISO13485. Certified as a lead 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.

Provide leadership to others through example and sharing of knowledge/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 top management, public groups, and/or boards of directors.

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.

SUPERVISORY RESPONSIBILITIES:

Supervisory responsibilities: Yes

Leadership: Yes

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

MANUAL DEXTERITY

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

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 an administrative nature.