Quality Assurance Specialist

Linde plc; Upper Saucon (Lehigh County); On-site; USD 90,000 - 130,000; Full time

Job summary

Linde plc in the United States seeks a Regulatory and Quality Systems Specialist to provide compliance support across multiple sites, aligning with FDA and GMP standards.

You will lead training for managers and staff, conduct site and vendor audits, prepare assessment reports, and drive continuous quality improvement while acting as a key advisor to QA leadership.

Qualifications

• Experience aligning with FDA and GMP standards across multiple locations.
• Ability to conduct audits and assessments of manufacturing sites, warehouses, and vendors to ensure compliance.
• Experience delivering training for managers, supervisors and personnel on company and regulatory procedures.
• Ability to communicate findings and improvement opportunities through detailed assessment reports.

Responsibilities

• Provide regulatory and quality systems support aligned with FDA and GMP standards across multiple locations.
• Lead training initiatives for managers, supervisors, and personnel on company and regulatory procedures.
• Conduct audits and assessments of manufacturing sites, warehouses, and vendors to ensure compliance with quality and regulatory requirements.
• Deliver detailed assessment reports and facilitate review meetings to communicate findings and improvement opportunities.
• Promote active participation in local quality meetings and foster a culture of continuous quality improvement.
• Serve as a compliance advisor to regional Quality Assurance leadership, supporting program development and implementation.
• Assist in investigating and managing customer complaints and internal nonconformances to drive resolution and corrective actions.
• Perform additional duties as needed to support quality assurance objectives and organizational goals.

Skills

Regulatory knowledge

Quality systems

Audits

Training leadership

Job description

What makes you great

• You will provide regulatory and quality systems support aligned with FDA and Good Manufacturing Practice standards across multiple locations


• Lead training initiatives for managers, supervisors, and personnel on company and regulatory procedures


• Conduct audits and assessments of manufacturing sites, warehouses, and vendors to ensure compliance with quality and regulatory requirements


• You are expected to deliver detailed assessment reports and facilitate review meetings to communicate findings and improvement opportunities


• Promote active participation in local quality meetings and foster a culture of continuous quality improvement


• Serve as a compliance advisor to regional Quality Assurance leadership, supporting program development and implementation


• You are going to assist in investigating and managing customer complaints and internal nonconformances to drive resolution and corrective actions


• Perform additional duties as needed to support quality assurance objectives and organizational goals

Why you will love working with us

Linde is a leading global industrial gases and engineering company with 2025 sales of $34 billion. We live our mission of making our world more productive every day by providing high-quality solutions, technologies and services which are making our customers more successful and helping to sustain, decarbonize and protect our planet.

Linde serves a variety of end markets such as chemicals & energy, food & beverage, electronics, healthcare, manufacturing, metals and mining. Linde’s industrial gases and technologies are used in countless applications, enabling space exploration and launch technologies, delivering ultra-high-purity and specialty gases for semiconductor manufacturing, providing life-saving medical oxygen and enabling clean hydrogen production and carbon capture to reduce greenhouse gas emissions. Linde also delivers state-of-the-art gas processing solutions to support customer growth, efficiency improvements and emissions reductions.

What we offer you!

At Linde, the sky is not the limit. If you’re looking to build a career where your work reaches beyond your job description and betters the people with whom you work, the communities we serve, and the world in which we all live, at Linde, your opportunities are limitless. Be Linde. Be Limitless.

Linde offers competitive compensation and an outstanding benefits package. Enjoy access to health, dental, disability, and life insurance, paid holidays and vacation, an employee discount program, and opportunities for educational and professional growth. Additional compensation may vary depending on the position and organizational level. Build your future with us while making an impact every day!

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, disability, protected veteran status, pregnancy, sexual orientation, gender identity or expression, or any other reason prohibited by applicable law.

Linde Gas & Equipment Inc. acts responsibly towards its shareholders, business partners, employees, society and the environment in every one of its business areas, regions and locations across the globe. The company is committed to technologies and products that unite the goals of customer value and sustainable development.

*The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Therefore employees assigned may be required to perform additional job tasks required by the manager.