Overview
Quality Engineer Jobs in London, KY at Aisin Automotive Casting, LLC
About USDM
USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what set us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.
As part of the USDM team, you have the opportunity to work with cutting-edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM’s clients. Are you ready to make an impact and drive real digital transformation in life sciences?
Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.
Nature and Scope of Job
The role of IT Validation Analyst will be accountable for performing processes relative to the IT Software Development Lifecycle and validation services applications and provide GXP guidance to project groups. This position works with the IT Validation and collaborates across and among key partners from Corporate Quality, Technical, Business and Solution teams. The aim is to ensure appropriate processes defined for CVS and Compliance are followed in an efficient and effective manner to satisfy business and regulatory requirements.
Primary Responsibilities
IT Validation –performing validation activities to implement and maintain IT systems.
Provides direction related to validation topics to project teams.
Authors and approves appropriate SDLC documentation to assess project teams in the development of software in a compliant manner.
Author GXP Assessments, Validation Plans, Validation Reports, Test Plans, Change Control documentations.
IT SDLC and Operations – Collaborates with Corporate Quality, Service Management, Testing and Release Management, Security, Application, and Infrastructure and Privacy teams as needed to champion the system development lifecycle and ensure the end-to-end process is effectively enabled.
Advises teams in how to apply risk-based approaches and effectively plan the SDLC activities required for their systems and projects.
Additional Responsibilities
Performs other related duties and assignments as required
Qualifications
This person should have 12 +years’ experience in SDLC/Computer Systems Validation or related position in SDLC or IT Quality/Compliance activities (preferably Pharmaceutical and/or Medical Device industries).
Experienced applying IT control methodologies and processes such as SDLC (Waterfall and Agile SCRUM), Change Management including GAMP5 and ITIL within a regulated environment.
Knowledge of GxPs regulations for medical device products, international requirements, and quality system development and management.
Explicit experience in EU regulations is a plus.
Document Management experience using ServiceNow Managed Documents, SAP Solution Manager and/or SAP DMS/ECM a plus.
Ability to communicate complex business / technical challenges in a simplified manner.
Build highly collaborative work style which includes working effectively globally and across all organizational levels in a highly matrixed organization.
Proven analytical, evaluative, and problem-solving abilities.
Excellent judgment and decision-making.
Strong, listening, creativity, and negotiation skills.
Education & Certifications
Bachelor’s degree in IT, business, finance, or a related field is required or 10+ years of IT compliance experience
Working Conditions
The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job and are not meant to be all-inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job.
Unless reasonable accommodations can be made, while performing this job the staff member shall:
Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment.
Operate other office productivity machinery, such as a calculator, scanner, or printer.
Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.
Equal Opportunity Statement
USDM Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Disclaimer
This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Compensation
Salary/Hourly Rate Range (W2): USD 80.00 – 90.00
The base salary/hourly rate range represents the anticipated low and high end of the USDM’s compensation range for this position. Actual salaries/hourly rates will vary and will be based on various factors, such as the candidate’s qualifications, skills, competencies, and proficiency for the role. The compensation described above is subject to change and could be higher or lower than the range described based on market survey data or budget.
Full-time employees are eligible for health, vision, and dental insurance, life insurance, short and long-term disability, hospital indemnity, accident, and critical care coverage.
Both full and part-time employees, who are at least 21 years of age, are eligible to participate in USDM’s 401k plan. Full and part-time employees may be eligible for paid time off.
All employees are eligible for USDM’s rewards and recognition program.
For more details about our benefits, visit us here: https://usdm.com/careers
Title: Quality Engineer
Company: Aisin Automotive Casting, LLC
Location: London, KY
