Quality Engineer II US

Adecco US, Inc.; Columbia (MD); On-site; USD 63,000 - 72,000; Full time

Job summary

Adecco US, Inc. is seeking a Quality Engineer II in Columbia, MD for a 3-month onsite assignment. The role focuses on GMP-based quality operations, validation, change management, and investigations within a regulated medical device site.

You will work with Engineering and Operations to support quality documentation, data analysis, and continuous improvement. Strong data integrity knowledge is a plus, and attention to regulatory standards is essential.

Qualifications

• Bachelor's degree in a scientific, engineering, or related field or equivalent experience.
• Experience in GMP, medical device, pharmaceutical, or other regulated environment.
• Strong experience with quality systems, change management, validation, or quality investigations.

Responsibilities

• Partner with Engineering and Operations on day-to-day quality activities and process improvements.
• Review, author, and support quality documentation including SOPs, validation protocols/reports, investigations, plans, and quality records.
• Support and maintain change management, validation, calibration, preventive maintenance, and environmental monitoring programs.
• Lead or participate in quality investigations including root cause analysis, corrective actions, and preventive actions.
• Review and analyze quality data, trending, and statistical information to support data-driven decisions.
• Support product and process changes, including quality impact assessments and implementation.
• Participate in internal and external audits including FDA, ISO, and customer audits.
• Work cross-functionally to support new and improved products/processes and technology transfer.
• Help ensure manufacturing and quality activities remain compliant with applicable regulations and quality standards.

Skills

GMP experience

Quality systems

Change management

Investigations

Data integrity

Education

Bachelor's degree in a scientific/engineering field

Tools

Microsoft Office

QMS systems

Job description

Quality Engineer II

Location: Columbia, MD

Schedule: Monday–Friday, 8:00 AM–5:00 PM

Pay: $46.00–$ 51.70/hour

Duration: Initial 3-month assignment with possible extension

Work Setting: 100% onsite

Overview

We are seeking a Quality Engineer II to support day-to-day quality and business operations at a regulated medical device site in Columbia, MD. This role partners closely with Engineering and Operations and is ideal for a Quality Engineer with strong GMP experience and a solid background in quality systems, validation, change management, and investigations.

Data Integrity experience is a major plus.

What You'll Do

• Partner with Engineering and Operations on day-to-day quality activities and process improvements.
• Review, author, and support quality documentation, including SOPs, validation protocols/reports, investigations, plans, and quality records .
• Support and maintain change management, validation, calibration, preventive maintenance, and environmental monitoring programs .
• Lead or participate in quality investigations , including root cause analysis, corrective actions, and preventive actions.
• Review and analyze quality data, trending, and statistical information to support data-driven decisions.
• Support product and process changes, including quality impact assessments and implementation.
• Participate in internal and external audits, including FDA, ISO, and customer audits .
• Work cross-functionally to support new and improved products/processes and technology transfer.
• Help ensure manufacturing and quality activities remain compliant with applicable regulations and quality standards.

What We're Looking For

• Bachelor's degree in a scientific, engineering, or related field ; equivalent relevant experience may be considered.
• Experience working in a GMP, medical device, pharmaceutical, or other regulated environment .
• Strong experience with quality systems, change management, validation, or quality investigations .
• Understanding of data integrity principles ; hands-on data integrity experience is a significant plus.
• Familiarity with 21 CFR Part 820/QMSR, 21 CFR Part 11, ISO 13485 , or similar quality/regulatory standards.
• Experience with quality documentation, SOPs, validation records, investigations, and/or quality systems.
• Strong analytical, organizational, communication, and project management skills.
• Ability to work independently while collaborating effectively with Engineering, Operations, and Quality teams.
• Proficiency with Microsoft Office and electronic quality/enterprise systems.

Ideal Background

This could be a strong fit for someone coming from a Quality Engineering, Quality Assurance, Validation, Manufacturing Quality, or Quality Systems background who enjoys working cross-functionally and wants a hands-on role supporting regulated manufacturing operations.

Key areas of experience: GMP, Quality Systems, Change Management, Validation, Quality Investigations, Data Integrity, CAPA, SOPs, Medical Devices, Regulated Manufacturing

Pay Details: $46.00 to $51.70 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.adecco.com/en-us/candidate-privacy

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.