Senior Manager of Quality Manufacturing - Plurogen

Location: Norristown, Pennsylvania, United States; onsite role with travel up to 25% within the state, nationally, and internationally.

Salary: $134,000–$201,000 annual, plus bonus and/or incentive eligibility.

Company

hirify.global is a growing worldwide healthcare organization providing medical products and offering employee development and total rewards programs.

What you will do

• Manage quality and regulatory compliance for assigned products, processes, and manufacturing departments.
• Ensure compliance with QSR, GMP, ISO, 21 CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR requirements.
• Coordinate with divisions, suppliers, manufacturing, operations, and customers to resolve quality issues.
• Manage complaints, investigations, corrective approaches, and continuous improvement projects.
• Support product evaluation, design controls, testing, inspection, and process validation activities.
• Lead day-to-day operations, staffing, performance management, training, work allocation, and policy implementation for assigned teams.

Requirements

• Bachelor’s degree in Engineering, Science, or a technical field, or equivalent experience.
• At least 4 years of experience with medical device or drug combination product platforms, design controls, risk management, and regulated quality systems.
• Broad knowledge of applicable standards and regulations, including QSR, GMP, ISO 13485, ISO 14971, MDSAP, and MDR.
• Ability to analyze and report data, coordinate concurrent projects, manage competing priorities, and meet critical deadlines.
• Advanced Microsoft Excel skills, including pivot tables and data analysis.
• Position requires travel up to 25% of the time; 2+ years of supervisory or managerial experience is preferred.

Nice to have

• Experience in medical device, pharmaceutical, food, cosmetic, or personal products industries.
• Supervisory or managerial experience.

Culture & Benefits

• Health insurance, life and disability coverage, 401(k) contributions, and paid time off for eligible employees.
• Continuing education and training opportunities.
• Employee Assistance Program, Employee Resource Groups, and Employee Service Corps access.
• Inclusive workplace focused on belonging, diversity, and career growth.