Senior Quality Engineer

Premier Group; Cambridge (MA); Hybrid; USD 120,000 - 145,000; Full time

Benefits offered by this job

Excellent Benefits

Job summary

Premier Group in Cambridge, MA is seeking a Senior Quality Engineer to support development and commercialization of cutting-edge medical devices. You will work across engineering, manufacturing, regulatory affairs and suppliers to ensure products meet the highest quality standards.

You will lead Design Verification & Validation, process validation, risk management and CAPA activities, while maintaining quality documentation and facilitating audits.

Qualifications

• BS or MS degree in Engineering, Science or a related discipline.
• 5+ years' Quality Engineering experience within medical devices, biotechnology or pharmaceuticals.
• Strong knowledge of FDA 21 CFR 820, ISO 13485 and ISO 14971.
• Experience with Design Controls, Risk Management and Validation activities.
• Strong understanding of CAPA and quality systems.
• Experience working within cross-functional engineering teams.
• Excellent communication and problem-solving skills.

Responsibilities

• Supporting new product development through all phases of design control
• Leading Design Verification & Validation activities, including protocol and report review
• Supporting process validation (IQ/OQ/PQ) and manufacturing transfer activities
• Managing quality documentation, engineering changes and document control
• Supporting risk management activities in accordance with ISO 14971
• Driving CAPA investigations, root cause analysis and continuous improvement initiatives
• Supporting internal and external audits
• Working with suppliers and contract manufacturers to maintain quality standards
• Ensuring compliance with FDA, ISO 13485 and other applicable medical device regulations
• Applying statistical methods to analyse data and improve manufacturing processes

Skills

Quality experience

Communication skills

Education

BS/MS in Engineering/Science

Job description

Boston / Cambridge, MA (Hybrid) $120,000 - $145,000 + Excellent Benefits

A growing medical device company developing innovative drug delivery technology is looking to appoint a Senior Quality Engineer to support the development and commercialization of cutting-edge products that will have a direct impact on patient care.

Working within a collaborative engineering environment, you\'ll play a key role across product development, manufacturing, quality systems and regulatory compliance, helping bring complex medical technologies from concept through to commercial production.

This is an excellent opportunity for an experienced Quality Engineer who enjoys working cross-functionally, solving technical challenges and influencing quality throughout the product lifecycle.

The Role

As the Senior Quality Engineer, you\'ll work closely with Engineering, Manufacturing, Regulatory Affairs and external suppliers to ensure products are developed and manufactured to the highest quality standards.

Responsibilities include:

• Supporting new product development through all phases of design control
• Leading Design Verification & Validation activities, including protocol and report review
• Supporting process validation (IQ/OQ/PQ) and manufacturing transfer activities
• Managing quality documentation, engineering changes and document control
• Supporting risk management activities in accordance with ISO 14971
• Driving CAPA investigations, root cause analysis and continuous improvement initiatives
• Supporting internal and external audits
• Working with suppliers and contract manufacturers to maintain quality standards
• Ensuring compliance with FDA, ISO 13485 and other applicable medical device regulations
• Applying statistical methods to analyse data and improve manufacturing processes

What We\'re Looking For

You\'ll ideally have:

• BS or MS degree in Engineering, Science or a related discipline
• 5+ years\' Quality Engineering experience within medical devices, biotechnology or pharmaceuticals
• Strong knowledge of FDA 21 CFR 820, ISO 13485 and ISO 14971
• Experience with Design Controls, Risk Management and Validation activities
• Strong understanding of CAPA and quality systems
• Experience working within cross-functional engineering teams
• Excellent communication and problem-solving skills