Quality Engineer I - Entry-Level, QMS & CAPA

Regulatory Jobs; Hudson (MA); Vor Ort; USD 64.000 - 93.000; Vollzeit

Benefits dieser Stelle

Medical, dental, vision

Disability and life insurance

401(k) with company match

Parental leave after one year

Holidays and paid time off

Zusammenfassung

Integer is seeking an entry-level engineer to support quality activities at our high-volume manufacturing site. You will apply general engineering methods under guidance from senior engineers to meet internal and external customer expectations while upholding our Quality Management System and regulatory requirements.

In this role you will assist with MRB, CAPA, change control, supplier quality, and product transfers; contribute to audits, non-conforming material handling, and continuous

Aufgaben

• Adhere to Quality Management System (QMS), safety, environmental and regulatory requirements (FDA, etc.).
• Support regulatory inspections, audits, investigations, and inquiries on product design and manufacturing quality.
• Monitor changes to BOMs, assembly procedures, drawings and specifications for accuracy.
• Participate in CAPA analyses and drive continuous improvement projects.
• Develop protocols and reports for test method validations and process capabilities.
• Lead disposition of non-conforming materials and supervise complaint investigations.
• Support internal quality audit activities and contribute to corrective/preventive actions.
• Promote standardization through 5S, standard work and training/certification.
• Engage associates, encourage problem-solving, and ensure effective communication.
• Align site quality activities with QA/RA metrics and strategic quality plans.

Jobbeschreibung

Integer is seeking an entry-level engineer to support quality activities at our high-volume manufacturing site. You will apply general engineering methods under guidance from senior engineers to meet internal and external customer expectations while upholding our Quality Management System and regulatory requirements.

In this role you will assist with MRB, CAPA, change control, supplier quality, and product transfers; contribute to audits, non-conforming material handling, and continuous