Quality Engineer: ISO 9001/IATF 16949 | Data-Driven QA

Altana Pharma Deutschland S.L. (Nycomed Germany Holding GmbH); City of Schenectady (NY); On-site; USD 85,000 - 100,000; Full time

Benefits offered by this job

Medical, dental and vision

Annual bonus

Retirement plan

Job summary

ELANTAS North America, Inc. in Schenectady, NY, seeks a Quality Engineer to develop, maintain, and champion the QMS across the organization. You will analyze data, drive corrective actions, and ensure ISO 9001:2015 and IATF 16949 compliance to boost customer satisfaction.

Responsibilities include serving as the quality contact for customers and suppliers, auditing, and supporting PFMEAs, Control Plans, and PPAPs, with 1–2 years’ experience and a B.S. in a related field.

Qualifications

• Bachelor of Science in Mechanical, Materials Engineering, or a related field.
• Familiarity with ISO 9001:2015 preferred.
• 1–2 years of quality engineering or manufacturing experience, incl. auditing and root cause analysis.
• Base Salary: $85,000 - 100,000/year, commensurate with experience.

Responsibilities

• Act as the primary contact for customers and suppliers on quality issues.
• Develop and implement procedures to meet quality goals and reduce waste.
• Maintain the Quality Management System (QMS) and related records.
• Collaborate with operations and engineering to improve manufacturing processes.
• Create and manage quality test procedures and documentation.
• Ensure compliance with ISO 9001 and IATF 16949 standards.
• Review engineering specs and ensure proper flow-down of customer requirements.
• Translate customer requirements into internal quality plans.
• Conduct internal and external audits.
• Perform root cause analysis and implement corrective actions.
• Support development of PFMEAs, Control Plans, and PPAPs.
• Train teams on new quality initiatives and projects.
• Monitor KPIs and respond to trends.
• Identify opportunities to improve customer satisfaction, product quality, and performance.
• Represent Quality in cross-functional meetings and decision-making.
• Apply statistical methods to support quality improvements.
• Prepare and present data-driven reports and recommendations.
• Ensure products meet company and industry quality standards.

Skills

Quality engineering

Root cause analysis

Auditing

Continuous improvement

Education

Bachelor's degree in Mechanical, Materials Engineering, or related field

Tools

ISO 9001 knowledge

IATF 16949 knowledge

Job description

ELANTAS North America, Inc. in Schenectady, NY, seeks a Quality Engineer to develop, maintain, and champion the QMS across the organization. You will analyze data, drive corrective actions, and ensure ISO 9001:2015 and IATF 16949 compliance to boost customer satisfaction.

Responsibilities include serving as the quality contact for customers and suppliers, auditing, and supporting PFMEAs, Control Plans, and PPAPs, with 1–2 years’ experience and a B.S. in a related field.