Careers

At FISBA, we take pride in fostering a collaborative culture for our employees.

Our Culture

At FISBA, we’re a performance-oriented photonics company that embraces open and collaborative communication, emphasizing trust and accountability. Our teams and company grow not only through active team cohesion initiatives but also through our company’s focus and support of the professional career development of every individual.

We know our best strategies arise from cross-organizational conversations rooted in mutual respect and shared leadership. Given this, our organizational culture prioritizes in-person interactions and robust connectivity with our remote employees and customers. Additionally, our leaders relinquish a measure of control over organizational content, and all team members actively participate in organizational planning and messaging. Self-discipline and accountability from top to bottom are the norm, with a particular focus on the context of the on-the-ground dynamics, as well as the important role that authentic motivation and influence plays in responding to change happening around us.

The dynamic and international environment regularly presents employees with new challenges and provides incentives for personal development. We offer career prospects in many areas including our state-of-the-art production facilities, design and engineering department, product management, manufacturing, and sales.

Benefits of Joining Our Team

  • Family-Friendly

    FISBA believes in enabling our employees to maintain a healthy work-life balance. We offer flexible working hours, part-time jobs, and full pay during maternity or paternity leave.

  • Training Opportunities

    The personal and professional development of our employees is very important to us. FISBA encourages internal and external courses and education.

  • Professional Rewards

    FISBA appreciates personal performance and commitment. Additional vacation days for company anniversaries are one of the small ways FISBA recognizes your contribution to our success.

Our Open Positions

Quality Manager Quality Engineering

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 focuses on solutions for Life Sciences, Advanced Manufacturing and Aerospace and Defense – always with the mission of empowering customers to exceed their goals.

We are seeking a Quality Manager to join our growing team! The Quality Manager is responsible for coordinating the activities required to meet quality standards as defined in the company’s Quality Management System (QMS).  Additionally, the Quality Manager will design and implement tests that effectively and efficiently monitor the quality of the medical device in each stage of the production process and participate in design-for-quality activities throughout the product design lifecycle.

 Permanent Location: Saco, Maine (initially reporting to Portland, Maine)

  • Implement process control, inspection, and validation of medical device manufacturing protocols.
  • Subject-matter-expert (SME) for the company’s QMS, including but not limited to:
    • Process management (including inputs and resources)
    • Production activities
    • Risk management
    • Change management and data collection
    • Supplier/Procurement management
  • Execute internal QMS and process audits as required.
  • Adhere to strict guidelines for quality and risk
  • Conduct training for Production, Engineering and QA personnel as requested
  • Oversee the CAPA process to ensure timely and effective corrective and preventive actions are implemented
  • Participate in Risk Management activities throughout the design process
  • Coordinate content and preparedness for management review meetings, ensuring that KPIs, trends, and improvement actions are effectively monitored and summarized
  • Lead QMS activities to maintain compliance to ISO 13485 and act as the organization’s ISO representative
  • Collaborate with other managers and staff throughout the organization to ensure Quality Systems are functioning properly.
  • Performs special assignments and other duties as assigned, including but not limited to hands-on inspection work during company manufacturing scale-up.
  • Bachelor’s degree (or equivalent work experience) in a relevant field.
  • 5+ years’ experience in a medical device manufacturing environment, including:
    • Strong knowledge of operating in an ISO 13485 compliant environment
    • Quality engineering for medical devices
    • Process and protocol validation
    • Internal and external quality audits
  • Demonstrated knowledge of Quality in a manufacturing environment with medical device contract manufacturing companies.
  • An independent, self-starter, who is detail oriented, organized, and able to prioritize and balance department workloads.
  • Must possess exceptional communication (written and verbal) skills; effectively set priorities, lead meetings; collaborate in a team setting; ability to interact effectively with all levels of the organization.

90,000 – 120,000 per year, DOE

  • The physical requirements are representative of the essential functions of the job with or without reasonable accommodations. An employee in this position is required to regularly stand, sit and walk. In addition, this position requires considerable manual dexterity for use of computer keyboard and mouse. The employee may also be required to walk through the manufacturing plant and will therefore be exposed to moderate noise levels. Reasonable accommodation will be considered on a case-by-case basis.
  • Lift and carry up to 25 pounds occasionally.

FISBA North America is an equal opportunity employer. We are committed to a diverse and inclusive workplace.

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.

 Permanent Location: Saco, Maine (initially reporting to Portland, Maine)

  • 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.
  • 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.

75,000 – 85,000 per year, DOE

  • 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.

FISBA North America is an equal opportunity employer. We are committed to a diverse and inclusive workplace.

Join Our Team

Interested in joining our team? Fill out and submit the form below, and one of our representatives will reach out to you shortly.

"*" indicates required fields

Max. file size: 50 MB.