Senior QMS Engineer

  • location: Pittsburgh, PA
  • type: Contract
  • salary: $36.66 - $50.24 per hour

job description

Senior QMS Engineer

job summary:
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
education: Bachelors
 
responsibilities:
- 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

 
qualifications:
  • Experience level: Experienced
  • Education: Bachelors
 
skills:
  • Quality
  • Medical Device
  • CAPA

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.

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