Software Validation Engineer
Buffalo, NY
Hybrid Position
$80k-$85k and Benefits Include - Health, Dental, and Vision insurance, 401K, Paid holidays and vacations, Tuition reimbursement program, Quarterly bonuses, Subsidized cafeteria costs, Peer recognition initiatives, Summer scholarships for children and grandchildren of employees, On-site gym
Job Summary
The Software Quality Engineer ensures the compliance of computerized systems validation (CSV) according to applicable procedures, regulations and industry standards. Their primary responsibility is to evaluate computerized systems based on applicability, functionality, and process and product safety. They will support management and maintenance of the software inventory and will provide support to all Company Product Facilities in the Computerized System Validation Process.
Job Duties
Implements and analyzes the applicability of the different norms and standards in the introduction and development of software for manufacturing processes, quality management systems, engineering, and support processes.
Participates on and supports engineering teams in projects for the introduction and development of manufacturing processes, quality management systems, and software.
Effectively leads, participates on, and/or monitors cross-functional teams related to CSV process/product improvement as required.
Develops quality plans, manufacturing, risk analysis, and process mapping related to the implementation of computerized systems.
Leads and/or supports the development and implementation of risk analysis tools, development controls, software verification, validations, test methods, procedures and work instructions, and new technologies related to computerized systems.
Ensures and participates in the application of quality controls during engineering runs, validation, production and design transfers.
Supports the qualification of new suppliers related to the development of computerized systems for manufacturing processes, quality management systems, engineering, and support departments. - Responsible for updating and implementing improvements to the software validation system and procedures.
Complies and writes training material and conducts training sessions on CSV process and activities.
Communicates with and addresses customer concerns as necessary.
May conduct internal audits and support external audits when necessary.
Demonstrates Company core values of honesty, integrity, and respect.
Other duties as assigned.
Impact
Recommend/create processes/procedures improvements
Analyze potential areas for savings or efficiencies.
Safety Responsibilities
Following all rules, regulations, and procedures set forth in the safety manual.
Promoting safety awareness throughout the workplace.
Alerting supervisors to any safety hazards they discover.
Wearing appropriate, proper protective equipment whenever required.
Using guards on tools and machinery whenever required.
Following proper lifting techniques using legs and not the back.
Operating any vehicles, equipment, tools, or machines only if they are authorized to do so.
Reporting any injury or loss immediately to the supervisor/team lead.
Promoting a positive attitude about safety and never performing any unsafe practice that could place the employee or others in danger.
Providing information to their immediate supervisor if a better and safer procedure can be implemented in performing any operation.
Assure when designing or modifying equipment/workstations that ergonomics and safety are reviewed and work to minimize hazards through engineering controls, administrative controls, and lastly personal protective equipment.
Assure Job Hazard and Equipment Hazard Analysis are completed timely as required.
Independent Judgment
Decide which projects are priority relative to company goals.
Determine best-in-class frameworks, systems, and processes.
Analysis/Problem Solving
Ability to read, analyze, and interpret the most complex documents.
Ability to find root causes and determine potential solutions.
Ability to comprehend and apply principles of advanced calculus, modern algebra, and advanced statistical theory.
Ability to work with concepts such as limits, rings, quadratic and differential equations, and proofs of theorems.
Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems.
Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, musical notes, etc.) in its most difficult phases.
Ability to work with a variety of abstract and concrete variables.
Communication
Ability to respond effectively in writing and verbally to the most sensitive inquiries or complaints.
Ability to make effective and persuasive speeches and presentations on controversial or complex topics to top management, customers, public groups, and/or boards of directors.
Skills/Technical Skills
ASQ, CQE or other relevant certification is a plus.
Communication Skills.
Working knowledge of traditional PC-based software such as Microsoft Office.
Requires an above-average people skills ability.
Knowledge
Understands regulated @type industries
Knowledge of medical device manufacturers and suppliers' knowledge preferred.
World-class manufacturing knowledge preferred.
Physical Requirements
While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; talk or hear; and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
Education
Bachelor's Degree (B.A. or B.S.) from a four-year college or university.
Experience
Minimum of 3 years of experience working with computerized systems validation.
Minimum 1-3 years working in a manufacturing environment in the medical device industry is preferred.
If you meet the above qualifications and would like to apply for this position, please click APPLY NOW and upload your most current resume or you may email your resume to our recruiter, Christine Hannon at christine.hannon@adeccona.com
Please include SOFTWARE on the subject line of any e-mail correspondence. Questions regarding this position can be addressed by emailing. Thank you in advance for applying, however, only qualified candidates will be contacted.
The Adecco Group is a Fortune Global 500 company and the global leader in Human Resource Solutions. Our group connects over 700,000 associates with our business clients each day through our 6,600 offices in over 70 countries and territories around the world. We offer employment opportunities at any stage in your Professional Career. For great opportunities near you, go to www.adeccousa.co (http://www.adeccousa.com/) m today!
Pay Details: $80,000.00 to $85,000.00 per year
Equal Opportunity Employer/Veterans/Disabled
To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.adecco.com/en-us/candidate-privacy
The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
The California Fair Chance Act
Los Angeles City Fair Chance Ordinance
Los Angeles County Fair Chance Ordinance for Employers
San Francisco Fair Chance Ordinance
