FISBA is a global company dedicated to shaping light through excellence in optical design, system engineering, high precision volume production and advanced optical coating. In the broad field of photonics, FISBA North America focuses on solutions for medical endoscopy and life science applications.
We are seeking a dedicated and passionate Quality Engineer to join our growing team! The Quality Engineer creates quality documents for new products and processes in optical system manufacturing. They oversee product quality from suppliers through purchasing controls, supplier qualification, and nonconformance management. Key tasks include internal QMS audits, change orders, QMS maintenance, quality testing coordination, corrective action resolution, and training. They optimize process controls, improve quality, cut costs, perform risk assessments, support new development, ensure compliance with standards, use quality tools, collaborate with teams, and assist in ISO 13485 audits.
Key Responsibilities:
· Author quality documents for new product development, process development, production, and operations.
· Implement process control inspection and validation for medical device manufacturing.
· Act as a subject-matter expert (SME) for the company's Quality Management System (QMS).
· Manage the quality of products from suppliers, ensuring compliance through proper purchasing controls, supplier qualification, and nonconformance management.
· Execute internal QMS and process audits.
· Support preparation of change orders and maintain the Quality Management System by revising SOPs, work instructions, and forms.
· Coordinate component and product quality testing.
· Resolve customer and supplier corrective action plans.
· Conduct training for Production and Engineering personnel.
· Develop and optimize process controls and quality system processes.
· Identify opportunities to enhance quality and reduce costs.
· Conduct product risk assessments and manage Product Risk Files (e.g., FMEA’s) per ISO 14971.
· Resolve quality issues by ensuring thorough root cause investigations and effective CAPAs.
· Support new product development and design transfer activities.
· Ensure compliance with applicable standards and regulations.
· Utilize quality engineering tools such as design of experiments, gage R&R, and process capability assessments.
· Collaborate with cross-functional teams to maintain and improve quality systems.
· Assist in internal and external audits, including ISO 13485 surveillance audits and customer audits.
Qualifications:
· Bachelor’s degree in a relevant field or equivalent work experience.
· 2+ years’ experience in a medical device manufacturing environment.
· Strong knowledge of operating in an ISO 13485 compliant environment.
· Experience with process and protocol validation, internal and external quality audits.
· Proficient in MS Office software (Word, Excel, Outlook, PowerPoint).
· Excellent communication skills, both written and verbal.
· Ability to prioritize and balance workloads effectively.
Salary Range: $75,000 – $85,000 per year, DOE
Physical Requirements:
· Regularly stand, sit, and walk.
· Manual dexterity for computer use.
· Occasionally lift and carry up to 25 pounds.
· Exposure to moderate noise levels in a manufacturing plant.
Equal Opportunity Employer: FISBA North America is an equal opportunity employer. We are committed to a diverse and inclusive workplace.
Location: Saco Maine
