Quality Specialist

IMA Life North America; City of Tonawanda (NY); On-site; USD 68,000 - 75,000; Full time

Benefits offered by this job

Global environment

Diversity & inclusion culture

Continuous learning

Wellbeing

Job summary

IMA Life North America is seeking a Quality Systems Specialist to maintain and improve the Quality Management System and support ISO 9001 compliance. The role involves handling nonconformances, CAPA, audits, and supplier quality activities, with focus on data analysis and continuous improvement across manufacturing processes.

Ideal candidates have 3–5 years in a manufacturing quality environment, with strong problem-solving, documentation, and collaboration skills.

Qualifications

• Education & Experience: Associate or Bachelor’s degree in a technical, engineering, manufacturing, or quality-related discipline preferred.
• Quality Systems Knowledge: working knowledge of ISO 9001, auditing practices, document control, corrective actions, and quality records management.
• Problem Solving: structured methods (5 Whys, Fishbone, CAPA, Lean, Six Sigma).
• Data Analysis Skills: data collection, trending and reporting quality metrics.
• Manufacturing Knowledge: familiarity with fabrication, machining, assembly, supplier quality.
• Communication & Collaboration: strong written and verbal skills across departments and suppliers.
• Computer Skills: proficiency in Microsoft Office and quality management systems.

Responsibilities

• Quality System Support: Maintain and improve QMS processes, records, procedures, and documentation per ISO 9001.
• Nonconformance & CAPA Coordination: process nonconformances, corrective actions, and preventive actions; support root cause investigations.
• Inspection & Compliance Activities: support inspections while ensuring adherence to specs and standards.
• Audit Execution: plan, support, and conduct internal audits; assist with customer/supplier audits.
• Supplier Quality Support: participate in supplier assessments and corrective action tracking.
• Data Analysis & Reporting: collect and report quality metrics and trends to support decisions.
• Document Control: manage quality records and controlled documents with accuracy and traceability.
• Continuous Improvement: participate in Lean, Six Sigma, and improvement initiatives.
• Training & Awareness: support quality training programs and promote awareness of standards.
• Safety & Compliance: promote safe practices and ensure compliance with OSHA, ISO, ASME, and customer requirements.

Skills

Quality Systems Knowledge

Problem Solving

Technical Aptitude

Data Analysis

Manufacturing Knowledge

Communication & Collaboration

Computer Skills

Education

Technical or quality-related degree (Associate or Bachelor)

Tools

Microsoft Office

Quality Management Systems

Job description

Who We Are

The IMA Group is a world leader in the design and manufacture of automatic machines for processing and packaging pharmaceutical, cosmetic, food, tea and coffee products, as well as in industrial process automation. We are constantly focused on innovation: through significant investments in R&D and ongoing dialogue with customers, local communities, and the supply chain, we promote an environmentally conscious approach aimed at achieving sustainable development. Our history is marked by steady growth, also supported by continuous investment in people and skills development. With more than 7,000 employees 59% in Italy and 41% worldwide we are present in over 80 countries.

IMA Life North America

IMA Life North America is a company within the IMA Group that specialises in providing aseptic processing and freeze-drying solutions for the pharmaceutical and biotechnology industries. IMA Life North America is part of IMA Life, a business unit focusing on the pharmaceutical sector who delivers advanced technologies for filling, lyophilisation and isolation, ensuring maximum sterility and product integrity for customers around the globe.

The Role

Primary Position Responsibilities

• Quality System Support: Maintain and improve Quality Management System processes, records, procedures, and documentation in accordance with ISO 9001 requirements.
• Nonconformance & CAPA Coordination: Process and track nonconformances, corrective actions, and preventive actions. Support root cause investigations and verify effectiveness of implemented actions.
• Inspection & Compliance Activities: Support incoming, in-process, and final inspection activities while ensuring adherence to engineering specifications and quality standards.
• Audit Execution: Plan, support, and conduct internal audits. Assist with customer, supplier, and external certification audits and follow-up activities.
• Supplier Quality Support: Participate in supplier assessments, issue resolution, corrective action tracking, and supplier performance monitoring.
• Data Analysis & Reporting: Collect, analyze, and report quality metrics, trends, KPIs, and defect data to support informed decision making and improvement efforts.
• Document Control: Manage quality records and controlled documents while ensuring accuracy, traceability, and compliance requirements are maintained.
• Continuous Improvement: Participate in Lean, Six Sigma, and continuous improvement initiatives focused on reducing non-conformances, improving process capability, and enhancing customer satisfaction.
• Training & Awareness: Support quality training programs and promote awareness of company standards, procedures, and customer requirements.
• Safety & Compliance: Promote safe working practices and ensure compliance with OSHA, ISO, ASME, customer, and company requirements.

This position may involve travel, primarily local travel of less than 10%.

Experience & Skills

Required Experience

• Education & Experience: Associate or Bachelor’s degree in a technical, engineering, manufacturing, or quality-related discipline preferred. Equivalent manufacturing quality experience of 3-5 years will be considered.
• Quality Systems Knowledge: Working knowledge of ISO 9001, auditing practices, document control, corrective actions, and quality records management.
• Problem Solving: Experience using structured problem-solving methods such as 5 Whys, Fishbone Analysis, CAPA, Lean, or Six Sigma tools.
• Technical Aptitude: Ability to interpret engineering drawings, specifications, inspection documents, and manufacturing requirements.
• Data Analysis Skills: Experience collecting, trending, and presenting quality performance metrics using common business software tools.
• Manufacturing Knowledge: Familiarity with fabrication, machining, assembly, supplier quality, or capital equipment manufacturing environments preferred.
• Communication & Collaboration: Strong written, verbal, and interpersonal skills with the ability to work effectively across departments and with suppliers.
• Computer Skills: Proficiency in Microsoft Office applications and quality management systems.

Compensation Package

$68,000-75,000

Bonus

What We Offer

• GLOBAL ENVIRONMENT: dynamic, flexible, avantguarde in a multinational and multicultural context.
• DIVERSITY & INCLUSION CULTURE: promoted through the Corporate Code of Ethics and dedicated programs.
• CONTINUOUS LEARNING: as a strategic asset for the development and motivation of people.
• WELLBEING: flexible working, health insurance, are just some of our initiatives to support the well-being of people and their families.

IMA IS AN EQUAL OPPORTUNITY EMPLOYER