Quality Engineer

SUMMARY: The Quality Engineerwill be responsible for developing, implementing, and maintaining quality standards across our products and processes. You will work cross-functionally to identify root causes, drive corrective actions, and champion a culture of continuous improvement throughout the organization.

WORK LOCATION:

This is a full-time, on-site position based at FHC’s facility in Bowdoin, ME. Regular physical presence is required to support hands-on activities.

ESSENTIAL DUTIES AND RESPONSIBILITIES: Other duties may be assigned.

• Operate within and actively support FHC's Quality Management System in accordance with ISO 13485:2016.
• Manage production processes to maintain and improve performance and reliability.
• Develop, implement, and maintain quality control plans, inspection criteria, and test procedures to ensure products meet specifications and customer requirements.
• Conduct root cause analysis (RCA) and lead corrective and preventive action (CAPA) initiatives in response to nonconformances, customer complaints, and internal findings.
• Collaborate with engineering, manufacturing, and supply chain teams to review designs, processes, and materials for quality risk in accordance with ISO 14971.
• Initiate, author, and/or contribute to Engineering Changes (ECs) as required; ensure timely closure in the quality management system.
• Perform process reviews, product inspections, and first article inspections (FAI) to verify compliance with internal standards and applicable regulations.
• Monitor and analyze quality metrics and KPIs such as defect rates, scrap, and yield, and report findings to management with recommended improvements.
• Maintain and manage quality documentation including SOPs, work instructions, inspection records, and quality reports.
• Support supplier quality activities including audits, qualification, and performance monitoring.
• Participate in design reviews and change control processes to proactively address quality risks.
• Ensure compliance with relevant industry standards, regulatory requirements, and customer-specific quality requirements.
• Drive continuous improvement projects using methodologies such as Lean, Six Sigma, or Kaizen.
• Author and execute validation plans including Installation (IQ), Operational (OQ), and Performance Qualifications (PQ) for process and software validations for production use.
• Monitor and improve production process performance and reliability; apply statistical methods as appropriate.
• Participate in internal and external quality audits as required; provide objective evidence and support timely resolution of audit observations.
• Participate and lead in critical supplier audits, some travel required.
• Maintain familiarity with sterilization techniques and the processes through which FHC products are packaged, sterilized, and validated.
• Develop and validate production-ready processes and process controls to meet established device specifications, support process transfer to manufacturing.
• Maintain familiarity with regulatory safety requirements for medical and research grade equipment
• Communicate with product users to gather feedback, provide technical support and troubleshoot problems
• Provide input on procedural support documents and user manuals for developed products
• Communicate clearly and concisely, both written and verbally, with management, cross-functional team members, contract manufacturers, suppliers, and end users.
• Provide reasonably accurate task effort estimates; communicate scope or timeline changes to the team as early as possible.
• Provide reasonably accurate estimations of the amount of work required for completion of assigned product development tasks. Alert team members as early as possible if estimates change during the development process.

COLLATERAL RESPONSIBILITIES:

• Maintain a positive attitude and a passion for excellence in customer service and for promoting the well-being of the company, its products, and its employees.
• Enthusiastically participate in company sponsored or other community events for the sake of charitable giving in the amount of 4 hours each quarter year.

QUALIFICATIONS:

• Excellent verbal and written communication skills, including technical writing of controlled documents (SOPs, work instructions, protocols, reports).
• Strong attention to detail and commitment to documentation accuracy within a regulated quality system environment.
• Ability to work collaboratively with cross-functional teams of varied backgrounds and skill sets.
• Demonstrated understanding of, or aptitude to learn, ISO 13485:2016 and related regulations.
• Familiarity with risk management principles (ISO 14971) is a plus.
• Familiarity with manufacturing engineering, GMP environments, or chemical safety is a plus.

Job Type: Full-time

Pay: $75,000.00 - $85,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Tuition reimbursement
• Vision insurance

Application Question(s):

• Will you require sponsorship?

Work Location: In person

Salary : $75,000 - $85,000