Senior Staff Quality Specialist

inSync Staffing; Franklin Lakes (NJ); Remote; USD 90,000 - 120,000; Full time

Job summary

A leading company in medical device manufacturing is seeking a Sr. Staff Quality Specialist to manage internal audits and ensure compliance with regulatory standards. The role involves collaboration with cross-functional teams and oversight of audit findings, focusing on CAPA management and regulatory compliance. Ideal candidates will have extensive experience in quality management and a strong understanding of industry regulations.

Benefits

Robust Health Insurance

401(k) plan

PTO accrual

Paid holidays

Excellent cash-based referral program

Qualifications

• 11+ years of experience in quality management focused on CAPA and audits.
• Strong knowledge of FDA, ISO, and GMP regulations.

Responsibilities

• Oversee the transition of audit findings to CAPA in TrackWise.
• Manage internal audit observations and ensure compliance.
• Prepare compliance reports for senior management.

Skills

Analytical

Problem-Solving

Communication

Organizational

Education

Bachelor's degree in Quality Management

Certification in Quality Management

Tools

TrackWise

Job description

Job Title : Sr. Staff Quality Specialist

Location : Remote

Industry : Medical Device Manufacturing

Job Description :

Theoris Services is assisting our client in their search for a Sr. Staff Quality Specialist to add to their growing team. Our client is seeking a highly motivated, collaborative, results-oriented and experienced person to join their team and help them deliver innovative medical devices to patients around the world. As a Sr. Staff Quality Specialist, you will play a crucial role in managing, reporting, and monitoring internal audit nonconformances. This position involves overseeing audit records, executing relevant metrics and reports, and ensuring compliance with regulatory and quality standards. You will work closely with cross-functional teams to track audit commitments, develop audit responses and plans, identify and mitigate risks, and resolve challenges. The ideal candidate will have a proven track record in managing complex projects, with a strong understanding of project management principles, audits, regulations, and compliance.

Responsibilities :

• CAPA Management :

Oversee the transition of audit findings from OneAudit system to the Corrective and Preventive Action (CAPA) in TrackWise.

• Collaborate with cross-functional stakeholders to ensure proper, timely, and accurate transitions.
• Maintain frequent communication on pertinent details of transitions with appropriate contacts.
• Audit Coordination :

Manage internal audit observations.

• Collaborate with cross-functional teams to ensure adherence to regulatory requirements and internal policies.
• Identify appropriate owners for audit findings and monitor audit phase timeliness.
• Serve as a liaison between owners and internal auditors.
• Identify areas of non-compliance and work with relevant departments to develop corrective action plans.
• Perform administrative tasks within the audit system, where appropriate.
• Regulatory Compliance :

Stay up to date with relevant industry regulations and standards.

• Ensure audit responses are complying and lead efforts to adapt to regulatory changes.
• Prepare compliance reports for senior management.

Lead and participate in continuous improvement initiatives related to monitoring the audit program and overseeing audit phase execution.

Requirements :

• Bachelor's degree in a relevant field (e.g., Quality Management, Regulatory Affairs, Life Sciences).
• 11+ years of experience in quality management with a focus on CAPA, audits, and regulatory compliance.
• Strong knowledge of quality management principles, methodologies, and relevant regulations (e.g., FDA, ISO, GMP).
• Proficiency in CAPA software and auditing tools (e.g., TrackWise).
• Excellent analytical, problem-solving, and communication skills.
• Certification in Quality Management (e.g., Certified Quality Auditor, Certified Lean Six Sigma) is a significant advantage.

Desired Skills :

• Exceptional attention to detail and commitment to data accuracy.
• Strong organizational and time management skills.
• Ability to lead and collaborate effectively in a cross-functional team environment.
• Analytical mindset with a passion for deriving insights from data.
• Demonstrated integrity in handling sensitive data and adherence to ethical standards.

We are in the people business; treating people right is our ONLY priority. Theoris Services consultants are full-time employees with full benefits, including :

• Robust Health Insurance
• 401(k) plan
• PTO accrual
• Paid holidays
• Excellent cash-based referral program

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Senior Quality Specialist • Franklin Lakes, NJ, US