Quality Engineer

Description

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Quality Engineer

Contract: Scarborough, Maine, US

Salary Range: 35.00 - 40.00 | Per Hour

Job Code: 370388

End Date: 2026-08-07
Days Left: 8 days, 3 hours left

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Position Details:
Client: Medical Devices Company
Position Title: Quality Engineer II
Duration: 05 Months (Possible extension)
Location: Scarborough, ME 04074 (Onsite)
Pay Range: $35/hr to $40/hr

Main Purpose of the Role:

• Works closely with development/manufacturing/quality engineering to establish and ensure compliance and quality for product related risk management documentation.
• Ensure risk management assessments and evaluations for products conform to established standards and agency regulations.
• This role will support product risk management activities across the product lifecycle, including evaluating risks associated with complaints, manufacturing non-conformances, and new product development.
• The Quality Engineer II will work cross-functionally with Engineering, Manufacturing, Regulatory, and Quality teams to establish and maintain compliant risk management documentation in alignment with FDA regulations and ISO standards.
• Responsibilities include performing hazard and risk assessments, contributing to continuous improvement of risk management processes, and ensuring product risk documentation is accurate, complete, and audit-ready.
• A strong understanding of complaint handling, health hazard assessments, and medical device regulatory environments is preferred.

Must Have Qualifications:

• Bachelor's degree in Engineering or related technical field
  Minimum 3 years of experience in quality engineering within a regulated environment (medical device, pharmaceutical, or similar)
• Hands-on experience with product risk management, including hazard analysis and risk assessments (ISO 14971)
• Experience supporting complaint investigations, non-conformance evaluations, or health hazard assessments
• Working knowledge of FDA regulations, ISO standards, and quality systems
• Proven ability to collaborate cross-functionally with Engineering, Manufacturing, and Regulatory teams
• Strong analytical, problem-solving, and documentation skills

Preferred:

• Certified Quality Engineer (CQE) or equivalent
• Experience with GMP environments and quality system audits
• Exposure to new product development and design assurance activities

Main Responsibilities:

• Perform risk evaluations associated with complaints, manufacturing non-conformances and new product design activities.
• Proactive in finding quality improvements related to Risk Management processes.
• Works cross functionally with Engineering, Marketing, Manufacturing and Regulatory to establish product risk documentation.
• Work collaboratively with operations engineering, complaint handling team, product development and design assurance.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Qualification:

• Education: Bachelors Degree in Engineering or related field. An equivalent combination of education and work experience
• Experience/Background: Minimum 2 years, in a medical device, regulatory environment or pharmaceutical manufacturing. Preferred understanding of complaint management and Health Hazard Assessments for on-market (distributed) products.
• Must have fundamental knowledge of concepts, practices, and procedures of a particular field of specialization. Credentials of a Certified Quality Engineer are a plus.
• Knowledge of GMP, ISO, FDA regulations, and quality systems auditing is desired.
• Must possess good communication and analytical skills. Ability to work under deadlines.
• Demonstrated use of Quality tools/methodologies.
• Solid communication and interpersonal skills.
• Ability to resolve quality-related issues in a timely and effective manner.
• Demonstrates technical leadership within the department and outside the department.
• Experience working in a broader enterprise/cross-division business unit model preferred.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.
• Strong organizational and follow-up skills, as well as attention to detail.
• Ability to travel, including internationally may be requested.

Benefits:
The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, longterm disability insurance, shortterm disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually AS Applicable)

Job Requirement

• Quality Engineer
• risk management

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• Recruiter
• Email
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• Anwesha Mohapatra
• View email address on click.appcast.io

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