Job Type: Full-Time / On-Site
Location: Brecksville OH (with a planned move to Wickliffe OH) or Wickliffe, OH
How You'll Make an ImpactAs a Senior Software Quality Assurance Engineer, you will be at the forefront of our quality excellence by establishing confidence in the software and digital systems used to support our Medical Device contract manufacturing operations. You will lead risk-based Computer Software Assurance and Computer System Validation activities and serve as a primary Quality resource for implementation and lifecycle management of the corporate electronic Quality Management System.
You will partner with Quality, Information Technology, business process owners, manufacturing sites, system owners, software suppliers, and implementation partners to ensure that regulated systems are fit for intended use, appropriately controlled, and maintained in a validated state . Oversee, coordinate, and control manufacturing for a team. This includes job assignments, monitoring work activities, resolving problems, performance reviews and related items on a day-to-day basis.
- Lead Risk-based Computer Software Assurance and Computer Systems Validation Activities used in Medical Device Production, Quality Management System Processes, monitoring and measurement and other regulated activities.
- Develop, Improve, Maintain Corporate Software Assurance and Validation processes and procedures for Medical Device Production.
- Oversee Software assessments - regulatory, intended-use, risk and validation.
- Provide Quality Oversight for system configuration, data migration, electronic workflows, audit trails, security roles, access controls, record retention, backup and recovery controls and all software validation activities.
- Collaborate with Business Process Owners, Systems Owners, Information Technology and implementation teams to ensure systems requirements are complete, testable, risk-based, and aligned with approved business processes.
Required Qualifications that Enable Your Success- Bachelor's degree in Engineering, Computer Science, Information Systems, Life Sciences, Quality, or related technical discipline.
- 5+ years of progressively responsible experience in Software Quality Assurance, Computer Software Assurance, Computer System Validation, Quality Engineering, or Quality Systems within the medical-device industry or another highly regulated life-sciences environment.
- Demonstrated experience applying risk-based Computer Software Assurance or Computer System Validation principles to software used in production or Quality Management System processes.
- Experience with and strong working knowledge of 23 CFR 11 requirements for electronic records and electronic signatures.
- Experience with and strong working knowledge of ISO 13485 and ISO 14971 and FDA Quality Management System Regulation 21 CFR Part 820 and the associated processes.
- Experience developing, reviewing, approving, or executing software assurance and validation deliverables, including requirements, risk assessments, validation plans, test evidence, traceability matrices, deviation records, and final reports.
- Working knowledge of GAMP 5 principles and risk-based lifecycle approaches for configured, commercial, cloud-based, or enterprise computerized systems.
- Strong technical-writing, analytical, problem-solving, project-management, and verbal communication skills.
- Ability to translate technical and regulatory concepts into practical requirements, risk decisions, validation strategies, and executive-level recommendations.
- Proficiency with Microsoft Office applications, including Excel, Word, PowerPoint, Teams, and SharePoint.
- Ability and willingness to travel to company manufacturing locations as required.
Preferred Qualifications That Drive You Forward- Experience implementing, validating, or maintaining a multi-site or enterprise eQMS.
- Experience with QAD eQMS, QAD ERP, or another enterprise Quality or manufacturing platform.
- Experience validating software-as-a-service, cloud-hosted, configurable commercial-off-the-shelf, or integrated enterprise applications.
- Experience in medical-device contract manufacturing, outsourced manufacturing, or an environment involving shared responsibilities among a manufacturer, customer, software supplier, and third-party implementation partner.
- Experience with regulated data migration, interface validation, master-data conversion, reconciliation, or legacy-system retirement.
- Experience assessing software suppliers, cloud-service providers, implementation partners, or vendor-provided validation and assurance documentation.
- Experience maintaining a computer-system inventory, validation master plan, software master file, periodic-review program, or validated-system lifecycle program.
- Experience leading or supporting software-validation, data-integrity, electronic-records, Part 11, or digital-quality audits.
- Experience supporting regulatory inspections, ISO 13485 certification audits, MDSAP audits, or medical-device customer audits.
- Experience with quality-system analytics, data visualization, reporting architecture, or governance of regulated Quality data.
- Familiarity with electronic document control, training management, CAPA, audit management, supplier quality, complaint management, change control, calibration, or other common eQMS modules.
- ISO 13485 Lead Auditor training or certification.
- ASQ certification, such as Certified Quality Engineer, Certified Quality Auditor, or Certified Software Quality Engineer.
- GAMP, computer-system validation, data-integrity, or Part 11 training or certification.
- Experience with organizational change management
Your Work EnvironmentAt Lubrizol, we're committed to providing a safe, inclusive, and empowering environment where you can do your best work-whether in a lab, on the production floor, or in a hybrid office setting. Depending on your role, your work environment may include:
- Vision correctable to 20/20.
- Hearing correctable to unamplified human voice.
- Manual dexterity: excellent
- Ability to meet safety, regulatory, and health guidelines without assistance.
- Continuous mental/visual concentration
- Ability to travel by auto/air unassisted.
Benefits that Empower You - Competitive salary with performance-based bonus plans
- 401(k) match + Age-Weighted Defined Contribution
- Comprehensive medical, dental & vision coverage
- Health Savings Account (HSA)
- Paid holidays, vacation, and parental leave
- Flexible work environment
- Learning and development opportunities
- Career and professional growth
- Inclusive culture and vibrant community engagement
Learn more at benefits.lubrizol.com!
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