Senior Quality Systems Leader (FDA/ISO 13485)

Pride Mobility Products Corporation; Duryea (Luzerne County); On-site; USD 67,000 - 82,000; Full time

Job summary

Pride Mobility Products Corporation seeks a senior Quality Leader to guide quality engineering initiatives across product, supplier, and regulatory domains. You will drive QMSR processes, CAPA investigations, and cross-functional improvements to ensure FDA and ISO compliance while enhancing product quality and customer satisfaction.

The role emphasizes leadership, risk management, and continuous improvement within a regulated manufacturing environment, with a focus on supplier development and

Qualifications

• Bachelor's degree required; advanced degree preferred.
• Minimum 5 years in quality engineering/assurance in regulated manufacturing.
• Experience leading audits and CI initiatives.
• Proven ability to manage CAPA programs and regulatory alignment.

Responsibilities

• Lead quality systems and regulatory compliance initiatives (FDA QMSR, ISO 13485).
• Drive QMSR/CAPA investigations, root-cause analyses, and corrective actions.
• Advise on risk management, document control, and audit readiness.
• Mentor quality staff and lead cross-functional teams on quality improvements.
• Develop and present high-level quality metrics and improvement plans.
• Oversee supplier quality and cross-functional supplier development efforts.
• Collaborate with R&D to ensure regulatory compliance in new product development.

Skills

Quality leadership

Regulatory compliance

CAPA investigations

Risk management

Data analysis

Cross-functional collaboration

Lean Six Sigma

Auditing

Education

Bachelor's Degree in Engineering

Tools

CAD

MS Excel

Statistical software

Job description

Pride Mobility Products Corporation seeks a senior Quality Leader to guide quality engineering initiatives across product, supplier, and regulatory domains. You will drive QMSR processes, CAPA investigations, and cross-functional improvements to ensure FDA and ISO compliance while enhancing product quality and customer satisfaction.

The role emphasizes leadership, risk management, and continuous improvement within a regulated manufacturing environment, with a focus on supplier development and