Quality Engineer II

Job Details:Quality Engineer II

Location : Scarborough ME

Duration: 05 Months

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.

QUALIFICATIONS 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.