Quality Specialist
IMA Life North America · Tonawanda, NY · 1 mo ago
On-siteQuality AssuranceFull-time
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. IMA Life North America, part of the IMA Life business unit, provides aseptic processing and freeze‑drying solutions for the pharmaceutical and biotechnology industries, delivering advanced technologies for filling, lyophilisation and isolation.
Responsibilities
- Maintain and improve Quality Management System processes, records, procedures, and documentation in accordance with ISO 9001 requirements.
- Process and track nonconformances, corrective actions, and preventive actions; support root‑cause investigations and verify effectiveness of implemented actions.
- Support incoming, in‑process, and final inspection activities while ensuring adherence to engineering specifications and quality standards.
- Plan, support, and conduct internal audits; assist with customer, supplier, and external certification audits and follow‑up activities.
- Participate in supplier assessments, issue resolution, corrective‑action tracking, and supplier performance monitoring.
- Collect, analyze, and report quality metrics, trends, KPIs, and defect data to support informed decision‑making and improvement efforts.
- Manage quality records and controlled documents, ensuring accuracy, traceability, and compliance.
- Participate in Lean, Six Sigma, and continuous‑improvement initiatives focused on reducing non‑conformances, improving process capability, and enhancing customer satisfaction.
- Support quality training programs and promote awareness of company standards, procedures, and customer requirements.
- Promote safe working practices and ensure compliance with OSHA, ISO, ASME, customer, and company requirements.
- Travel primarily local, less than 10 % of time.
Requirements
- Associate or Bachelor’s degree in a technical, engineering, manufacturing, or quality‑related discipline preferred; 3‑5 years of equivalent manufacturing quality experience considered.
- Working knowledge of ISO 9001, auditing practices, document control, corrective actions, and quality records management.
- Familiarity with fabrication, machining, assembly, supplier quality, or capital‑equipment manufacturing environments preferred.
Skills
- Structured problem‑solving methods (5 Whys, Fishbone Analysis, CAPA, Lean, Six Sigma).
- Ability to interpret engineering drawings, specifications, inspection documents, and manufacturing requirements.
- Data‑analysis expertise: collecting, trending, and presenting quality performance metrics using common business software tools.
- Strong written, verbal, and interpersonal communication; effective collaboration across departments and with suppliers.
- Proficiency in Microsoft Office applications and quality‑management systems.
Pay
Salary range: $68,000 – $75,000 plus bonus.
Benefits
- Dynamic, flexible, avant‑garde global environment in a multinational and multicultural context.
- Diversity & inclusion culture promoted through the Corporate Code of Ethics and dedicated programs.
- Continuous learning opportunities as a strategic asset for development and motivation.
- Well‑being initiatives including flexible working and health insurance for employees and families.