Quality Assurance Engineer Staff

hace 2 semanas

Alajuela, Alajuela, Costa Rica Confluent Medical Technologies A tiempo completo

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 RESPONSIBILITIES include the following. Other duties may be assigned.

Implement methods and/or procedures for inspecting, testing and evaluating the precision and accuracy of products and/or production equipment. Diagnose and resolve manufacturing and quality system issues. Participate in performing design, optimization, validation and production readiness reviews, to ensure the safe and environmentally sound start-up of new processes. Generate and maintain risk management files supporting product and process development, such as Risk Management Plans/Reports, Hazard Analyses, FMEAs, Design Trace Matrices, Post Market Surveillance plans and other related documents. Provide guidance and generate reports for topics involving statistical analysis, including sample size requirements, process capability analysis, regression analysis, tolerance Interval Analysis, ANOVA. Support Product/Process Development Engineering in Optimization activities by guiding Design of Experiments of various process parameters and analyzing data. Write Process Validation and Test Method Validation Protocols, analyze data and write and release validation reports. Creates Test Methods for new processes, including protocols, reports and execution. Communicate with Customer as needed on Process Development Responsibilities, Quality Issues and/or Supplier Initiated Change Requests.

SUPERVISORY RESPONSIBILITIES :

Have supervisory responsibilities: Yes

Leadership: N/A

Supervises: N/A

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, Transfer, Risk Management etc) 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.

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.

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