Quality Engineer II

We are looking for Quality Engineer II for our client in Scarborough, ME

Job Title: Quality Engineer II

Job Location: Scarborough, ME

Job Type: Contract

Job Overview:

Requirement/Must Have:

• 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.

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.
• Work cross-functionally with Engineering, Marketing, Manufacturing, and Regulatory to establish product risk documentation.
• Collaborate with operations engineering, complaint handling team, product development, and design assurance.
• Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Nice to Have:

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

Qualification And Education:

• Bachelor s Degree in Engineering or related field.
• An equivalent combination of education and work experience.
• Minimum 2+ years in a medical device, regulatory environment, or pharmaceutical manufacturing.
• Preferred understanding of complaint management and Health Hazard Assessments for on-market products.
• 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.
• 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 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.