Quality Manager PPP NA

Centor Rx; Millersburg (OH); On-site; USD 90,000 - 130,000; Full time

Job summary

Centor Rx in Millersburg, OH, seeks a Quality Manager PPP NA to oversee all QA activities, ensuring compliance with internal procedures and product requirements. Lead QMS implementation, audits, and CAPA processes to maintain high quality across operations.

This role requires a Bachelor’s or Master’s in Engineering or Quality Management with 5+ years of leadership experience, plus strong knowledge of Six Sigma, Lean, and ISO standards.

Qualifications

• Bachelor’s or Master’s degree in Engineering or Quality Management; 5+ years experience.
• Experience leading quality teams and implementing improvement processes for at least 2 years in a leadership role.
• Strong knowledge of quality control tools (Six Sigma, Lean, SPC) and ISO standards.

Responsibilities

• Quality System Implementation and Maintenance in conformance with cGMP, ISO standards, and regulatory requirements.
• Oversee QA and QC processes including audits, inspections, CAPA and supplier quality interactions.
• Drive continuous improvement to enhance product quality and operational efficiency.
• Provide leadership and training to the quality team; manage QA/QC teams.
• Interface with regulatory agencies and customers, and report quality metrics.

Skills

Quality leadership

Six Sigma

Lean

SPC

Regulatory knowledge

Team management

Analytical thinking

Communication

Education

Bachelor’s or Master’s in Engineering

Quality Management degree

Job description

Main tasks

The Quality Manager PPP NA, Gx Berlin, Ohio, is responsible for overseeing all aspects of the quality assurance activities within PPP NA to ensure compliance with internal procedures as well as applicable product and customer requirements. The Quality Manager ensuring the quality control processes in an organization to ensure products and services meet defined standards and customer expectations.

Main tasks

The Quality Manager PPP NA, Gx Berlin, Ohio, is responsible for overseeing all aspects of the quality assurance activities within PPP NA to ensure compliance with internal procedures as well as applicable product and customer requirements. The Quality Manager ensuring the quality control processes in an organization to ensure products and services meet defined standards and customer expectations.

Area of responsibility

Quality System Implementation and Maintenance

• Develop, implement, and maintain quality management systems (QMS) in compliance with cGMP, ISO 9001, ISO 15378, ISO 14001, ISO 45001 and other regulatory standards.
• Lead quality assurance activities, including audits, inspections, and risk assessments.

Quality Assurance and Control

• Oversee the quality control process, including incoming raw materials, in-process checks, and final product inspections.
• Ensure compliance with FDA regulations, including 21 CFR Part 820 and other applicable requirements.
• Manage non-conformance investigations, CAPA (Corrective and Preventive Action) processes, and root cause analysis.

Continuous Improvement

• Develop and implement process improvements to enhance product quality and operational efficiency.
• Collaborate with cross-functional teams, including production, engineering, and regulatory affairs, to maintain high-quality standards.

Leadership and Team Management

• Provide leadership and training to quality team members, ensuring adherence to best practices.
• Lead and manage quality assurance and control teams.

Communication and Collaboration

• Serve as the primary point of contact for regulatory agencies and customers regarding quality-related matters.
• Maintain accurate documentation and reporting of quality metrics and compliance data.
• Communicate quality issues and performance data to management and stakeholders.
• Interface with customers and suppliers on quality matters.

Qualifications

• Bachelor’s degree and/or Master’s degree in Engineering, Quality Management, or a related field with at least 5 years experience (or equivalent experience).
• Proven experience in quality management or a similar role, preferably in the relevant industry.
• The ability to lead a team and implement quality improvement processes with at least 2 years of proven experience in a leadership role.
• Strong knowledge of quality control tools, such as Six Sigma, Lean, or SPC (Statistical Process Control).
• Familiarity with industry standards (ISO 9001, ISO 15378, ISO 14001, ISO 45001, etc).
• Experience in the plastic injection molding and/or medical device industry preferred.
• Excellent analytical, problem-solving, and communication skills.
• Ability to lead teams and drive continuous improvement.