Software Quality Engineer II (Chicopee)
Employment Type: Full-Time
Industry: Information Technology
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PURPOSE AND SCOPE:
The main scope of this position is to ensure that FMCNA regulated computer systems are developed, validated, and maintained in compliance with corporate software validation lifecycle policies and procedures.
PRINCIPAL DUTIES AND RESPONSIBILITIES : Developing professional expertise, applies company policies and procedures to represent the Quality Systems Department on software development teams as a software validation partner. Partners with business teams and IT to ensure that computerized quality systems are compliant with FMCNA procedures, FDA Quality System Regulations, 21 CFR Part 11, and GAMP5. Creates and/or oversees the creation of validation deliverables including but not limited to validation assessments, validation plans, test plans, test protocols, test reports, validation summary reports, and trace matrices, as needed to support local and enterprise system implementation in a regulated (FDA) environment. Leads the review and approval of validation deliverables. Executes test protocols as necessary. Conducts independent reviews of test executions. Assists business owners/teams and IT in the definition and creation of business requirements, functional specifications, and system specifications as necessary. Compiles and maintains approved project deliverables. Communicates project and compliance issues to Quality Systems management. Supports internal and external regulatory audits/inspections by presenting and defending system validation projects and documentation during audits and FDA inspections as Subject Matter Expert. Provides guidance/direction to external contractors working on system validation projects. Ensures that pertinent validation deliverables are of high product quality and are compliant with the FMCNA policies/procedures. Works with moderate supervision to fulfill duties in accordance with requirements of the QSR regulations, GAMP5, Corporate policies and procedures. Follows all policies, guidelines, and SOPs as required. Normally receives general work instructions on routine work, detailed instructions on new projects or assignments. Works on problems of moderate scope where analysis of situation or data requires a review of a variety of factors. Exercises judgment within defined procedures and practices to determine appropriate action. Builds productive working relationships. May refer to higher level staff for assistance with higher level problems that may arise. Escalates issues to supervisor/manager for resolution, as deemed necessary. Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations. Assists with various projects as assigned by direct supervisor. Other duties as assigned.
Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions .
PHYSICAL DEMANDS AND WORKING CONDITIONS: The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Extended computer-based work in an office environment.
Bachelors Degree required in Computer Science, Software Engineering, or related field.
EXPERIENCE AND REQUIRED SKILLS: Minimum 2 5 years of experience in software engineering, information technology, or software quality assurance in a regulated environment; with an advanced degree no prior experience may be acceptable. Understanding of FDA Quality System regulations in relation to computer system validation ASQ CSQE Certification or equivalent desired. Experience with one or more of the following highly desirable: SAP, PTC, WindChill, Pilgrim. Good verbal and written communication skills. Good team work and interpersonal skills. Strong analytical and problem solving skills. Excellent attention to detail, resourceful, self-reliant, self-motivated and confident.
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity
Associated topics: performance test, process, prevent, quality, quality assurance engineer, software quality, software quality engineer, software quality assurance engineer, test, tester
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