Top Medical Device Company - Quality Engineer

Insight Global; Raynham (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

Insight Global is seeking a Quality Engineer to support the QMS and ensure ISO13485 compliance. You will partner with management to uphold the QMS and provide shop floor engineering support to maximize uptime and high product quality.

The role requires 3–5 years of quality engineering experience in medical devices, with strong knowledge of CAPA, MRB, FAI and metrology tools. Experience with audits and ERP systems is a plus. Fluency in English and proficiency with MS Office are expected.

Qualifications

• 3–5 years of quality engineering experience in medical device components.
• Strong understanding of ISO13485 QMS and regulatory requirements.
• Experience with CAPA, MRB, NCMR, FAI and KPI improvement.
• Proficiency in metrology tools and reading drawings (GD&T).
• Experience with audits/inspections is a plus.

Responsibilities

• Supports the maintenance of the QMS ensuring its continuing suitability, adequacy and effectiveness.
• Shop floor support for troubleshooting, root cause analysis, support production uptime with engineering.
• Lead CAPA ownership and MRB processes where applicable.
• Support the Equipment Qualification and Validation Process (IQ, OQ and PQ).
• Drafts and executes protocols with Engineering.
• Nonconforming Material System (NCMR) ownership and MRB involvement.
• Performs First Article Inspections (FAI) with QC personnel.
• Supports Measurement System Analysis (Gage R&R) where applicable.
• Supports KPI improvements and business objectives.
• Supports ASL evaluations, reporting and feedback.
• Creates and edits SOPs, Work Instructions and forms.
• Provides input to FMEAs / Risk Management.
• Performs product quality inspections as needed.
• Performs calibration of measuring and monitoring equipment.
• Provides training as needed.

Skills

Quality engineering

ISO13485

CAPA

Gage R&R

First Article Inspection

Minitab

GD&T

English communication

ERP systems

MS Office

Tools

QMS software

Visio

Word

Excel

PowerPoint

Job description

The Quality Engineer is responsible for supporting the effectiveness of the Quality Management System (QMS) and to ensure compliance of QMS activities to ISO13485:2016. Partner with management team to ensure adherence to the QMS. Provide consistent product and process support for shop floor manufacturing to ensure maximized uptime and high product quality is achieved.

ESSENTIAL FUNCTIONS

• Supports the maintenance of the QMS ensuring its continuing suitability, adequacy and effectiveness
• Shop floor support for troubleshooting, root cause analysis, support production uptime with engineering
• Red Cart Process and Gemba Walk
• Corrective and Preventive Action System (CAPA) ownership
• Support the Equipment Qualification and Validation Process (including IQ, OQ and PQ, etc)
• Works with Engineering to draft and execute protocols
• Nonconforming Material System (NCMR) ownership and leads the MRB process where applicable
• Performs First Article Inspections (FAI) with QC Personnel
• Where applicable, creates and executes Measurement System Analysis (Gage R&R)
• Support day to day operations to drive Key Process Indicator (KPI) improvements and business objectives
• Supports the Approved Supplier List (ASL) Evaluations, Reporting and Feedback
• Creates and edits Standard Operating Procedures, Work Instructions and Forms
• Provides input to FMEAs / Risk Management
• Performs Product Quality Inspections as needed
• Performs Measuring and Monitoring Equipment Calibration as needed
• Performs Training as needed
• Perform other relevant duties as assigned by supervisor

SPECIFIC JOB KNOWLEDGE, SKILL AND ABILITY

The individual must possess the following knowledge, skills and abilities and be able to explain and demonstrate that he or she can perform the essential functions of the job, with or without reasonable accommodation.

• Full understanding of a QMS and conformance to ISO13485
• Nonconforming materials, calibration, corrective and preventive actions, root cause analysis, etc
• Experience in medical component or medical device manufacturing required
• Proficient in use of metrology (hand devices, vision systems, microscopes, non-contact devices, profilometer)
• Basic proficiency in reading drawings, GD&T and blueprints
• Ability to read, listen and communicate effectively in English, both verbally and in writing
• Experience in customer, registrar or FDA audits/inspections a plus
• Ability to navigate a computer ERP system, in certain modules, and perform data entry, data retrieval
• Computer Skills – Microsoft Office Suite: Word, Excel, Powerpoint, Visio required (QMS software and Minitab experience a plus)
• Willingness to continually work beyond scope of essential duties in order to assist whenever and wherever needed to ensure company needs are met

QUALIFICATION STANDARDS

Experience:

3 to 5 years of related experience in quality engineering in medical device or medical components