What are the responsibilities and job description for the QE Lead/ QE Manager at Rochester, NY position at SR Partners LLC?
Job description
Role: QA Automation Manager
Locations: Rochester, NY
Experience: 7 years of progressive experience in Quality
JD:
The Responsibilities
- Lead, develop, and inspire a team of Quality professionals to achieve organizational and individual performance objectives.
- Establish clear priorities, assign responsibilities, and ensure effective resource allocation to meet business and compliance needs.
- Coach and mentor emerging Quality leaders and technical experts to build organizational capability and ensure robust succession planning.
- Model QuidelOrtho's leadership principles by demonstrating collaboration, accountability, inclusion, and service mindset in all interactions.
- Provide technical, regulatory, and operational leadership to ensure Quality systems comply with ISO 13485, FDA 21 CFR 820, IVDR, and other applicable requirements.
- Partner with Manufacturing, R&D, Regulatory Affairs, Supply Chain, and other stakeholders to integrate Quality and Compliance principles throughout the product lifecycle as applicable.
- Ensure the team maintains a state of inspection readiness and supports successful engagement with regulatory agencies, notified bodies, and internal audits.
- Team serves as the primary quality escalation point for manufacturing concerns, ensuring rapid assessment and resolution. Providing real-time quality support to production to maintain operational continuity while ensuring compliance.
- Team review and approve manufacturing deviations, rework instructions, and other quality-impacting actions. Ensuring that all quality decisions are risk-based, well-documented, and compliant with applicable standards and regulations. Acting as the quality authority for batch release support, as applicable.
- Support harmonization and standardization of Quality processes, procedures, and tools across sites and functions to strengthen compliance and efficiency.
- Promote a culture of continuous improvement by identifying opportunities for simplification, process excellence, and digital enablement within the Quality Management System (QMS).
- Monitor Quality performance using metrics and data analytics to identify risks, drive root cause analysis, and implement sustainable improvements.
- Perform other work-related duties as assigned.
Required:
- Bachelor's degree in Life Sciences, Engineering, or a related technical discipline required.
- 7 years of progressive experience in Quality, Compliance, or related fields within the Medical Device, IVD, or Biopharmaceutical industries, including at least 3 years in people leadership.
- Understanding of Quality System regulations and standards, including ISO 13485, FDA 21 CFR 820, and IVDR.
- Proven ability to lead and develop high-performing teams and build future technical and people leaders.
- Demonstrated success driving Quality and Compliance initiatives that align with business strategy and regulatory expectations.
- Excellent collaboration, influence, and communication skills across functional and organizational boundaries.
- Strong analytical and problem-solving skills, with experience using data to drive decision-making and improvement.
- Experience leading in a matrixed, global organization and managing competing priorities effectively.
- Commitment to scientific integrity, compliance excellence, and continuous improvement.
PSRTEK is a reputed technology recruitment and IT staffing brand with a global footprint and an admired client base. As an ideas and innovation powerhouse with a culture of excellence, we bring remarkable expertise and deliver powerfully transformative results.