A Senior QMS Engineer is needed for a leader in electronics, healthcare, and lighting in the Pittsburg, PA area. This job maintains a compliant, lean and effective MS/QMS. Partners across the business to continually improve and standardize SRC's MS/QMS structure, documents and systems. Monitors, measures, and drives in-scope functional & process performance (both on-going and strategic).
location: Pittsburgh, Pennsylvania
job type: Contract
salary: $36.66 - 50.24 per hour
work hours: 8am to 5pm
- Ensures external and internal audit readiness and provides support during external and internal audits
- Reviews Quality plans to ensure compliance/conformance to FDA regulations and other Regulatory Agency and consensus standard requirements
- Ensures adequate service levels and quality for document control, records management, software validation, CAPA, Quality Planning, Management Review QMS processes; monitoring and assurance of process performance
- Owns QMS CAPAs, develops adequate and defensible root cause analyses and action plans; completes plans to schedule
- Actively assists in managing a program of CAPAs; accountable for timely and comprehensive corrective and preventive management of issues/opportunities
- Actively assists in managing a program of Quality Plans; accountable for plan accuracy and on-schedule plan closure
- Proactively identifies areas of emerging risk and advises on directions for future areas of analysis/development
- Acts as QMS competence expert, coaching and developing skills and knowledge within the QMS team
- Promoting Q&R awareness level as determined within the organization
- Establishes an effective Management Review process, including routine reporting
- Managing the strategic improvement processes ('breakthrough Program') in the Business (One Page Strategy, Hoshin Plan)
- Participates in Quality & Regulatory initiatives as a cross functional contributor
- Establishes and assures adherence to schedules, work plans and performance requirements
- May manage or oversee individual contributors
To succeed in this role, you should have the following skills and experience:
-Minimum of 7 years of experience working in disciplined regulated industry and in the application of automated technology, particularly 21 CFR, ISO 13485, GAMP 5.
-Understanding and application of appropriate global medical device regulations, requirements and standards, including FDA's 21 CFR 820, ISO 13485, EU Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, ANVISA, ISO 14971, ISO 9001, and others including familiarity with the European Medical Device Regulation MDR 2017/745.
-Experienced Engineer with proven success within teams and delivering on organizational objectives
-Proven experience in Quality Management System processes, including cross sector or business process standardization, ensuring effectiveness and efficiency while maintaining compliance with worldwide regulations
-An ability to successfully communicate and educate Quality Management System regulations, policies and strategies to teams at all levels of the organization
-Experience in corrective and preventive actions, including root cause analysis, documenting findings/actions, and implementing actions.
-Advanced Analytical Skills; demonstrated ability to troubleshoot complex process/system issues
-Project Management (development of project plans, status meetings, project reporting, etc.) and organizational change management
-strong communication skills; ability to prioritize and manage multiple simultaneous programs/projects
-strong IT Skills
- Experience level: Experienced
- Education: Bachelors
- Medical Device
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.