2nd Shift Quality Engineer - Medical Devices Leader

Cirtec Medical; Lowell (MA); Sur place; USD 100 000 - 130 000; Plein temps

Avantages offerts par ce poste

Training and career development

Healthcare & well-being programs

Paid Time Off

401(k) with company match

Résumé du poste

Cirtec Medical, a leading medical device contract manufacturer, seeks a Senior Quality Engineer (2nd shift) to provide hands-on quality engineering for manufacturing of device components. You will be the technical quality lead on production lines, ensuring process stability and driving quality improvements.

You will collaborate across functions to meet production and quality goals, develop QA plans, and support CAPA, ICQ/OQ, and supplier quality activities.

Qualifications

• Bachelor's degree in a STEM discipline
• 5 years of quality engineering experience
• Experience with ISO 13485 and GMP
• Fluent in Microsoft Office
• Must be able to perform root cause analysis and implement corrective actions
• Experience with MES/ERP systems

Responsabilités

• Provide Quality Engineering support for manufacturing and product development.
• Manage verification/validation master plan and determinations.
• Develop and maintain SOPs and Quality Plans.
• CAPA system owner or support for corrective actions.
• Audit support for third party, customer, and internal audits.
• Drive continuous improvement initiatives and production quality control plans.
• Lead or support FMEA and DOE as applicable.

Connaissances

Quality engineering

Root cause analysis

CAPA

FMEA

DOE

ISO 13485 / GMP

MES / ERP systems

Statistical analysis (Minitab)

Microsoft Office

Documentation control

Formation

Bachelor's degree in a STEM discipline

Outils

Minitab

ERP systems

Description du poste

Cirtec Medical, a leading medical device contract manufacturer, seeks a Senior Quality Engineer (2nd shift) to provide hands-on quality engineering for manufacturing of device components. You will be the technical quality lead on production lines, ensuring process stability and driving quality improvements.

You will collaborate across functions to meet production and quality goals, develop QA plans, and support CAPA, ICQ/OQ, and supplier quality activities.