Quality Engineer

HOYA Group•Ramsey, MN

25d•Onsite

About The Position

HOYA Vision Care is seeking a Quality Engineer for its Ramsey, MN location. This role is responsible for ensuring that products, processes, and quality systems comply with internal requirements, customer expectations, and regulatory standards. The Quality Engineer will support the Quality Department in the establishment, maintenance, and continuous improvement of the Quality Management System (QMS), risk management activities, validation and qualification programs, audits, CAPA investigations, and continuous improvement initiatives in alignment with ISO 13485/FDA compliance and other applicable regulatory requirements. This position will collaborate closely with Operations, Engineering, R&D, and Global/regional Quality functions to drive product quality, process effectiveness, compliance, and customer satisfaction supporting ATC (R&D), Mass Operations, and Rx functions.

Requirements

Bachelor’s degree (Engineering, Science, or related field preferred) or commensurate offsetting experience in Quality Engineering
5+ years hands-on experience in medical device quality
Experience with FDA regulated products and ISO 13485 certified QMS
Experience in product development including implementing appropriate controls
Working knowledge of statistics is required
Proficiency with Minitab, MS Outlook, MS Word, and MS Excel
Attention to detail and excellent problem-solving skills
Excellent written and verbal communication skills
Ability to identify potential roadblocks and provide innovative solutions
Ability to work independently and in a collaborative team environment
Operate with a high level of integrity and professionalism
Ability to learn new software programs as required

Nice To Haves

Experience with QMS development is a plus
Six Sigma Green Belt (or higher) certification being a plus
Working knowledge of FDA regulations (21 CFR 820) and other relevant standards is strongly preferred
Experience in a medical device start-up environment is strongly preferred
ASQ certification as a Quality Engineer is a plus
Experience in performing QMS audits is preferred, with certification as a Quality Auditor being a plus
Experience in optics/ophthalmics is a plus
Experience with ISO 14971 risk management is a plus
Ability to travel up to 10%
Humble, hungry, and People-smart with a willingness to learn and grow
Find fulfillment in building and maintaining QMS’s and supporting a quality culture
Thrive in a dynamic environment with continually shifting priorities
Ability to manage communication and training with knowledge of different training techniques

Responsibilities

Support the Quality Team with QMS establishment, maintenance, and continuous improvement
Collaborate with cross functional teams to provide quality leadership, guidance, training, and support in QMS implementation/execution.
Support validation activities including IQ/OQ/PQ and TMV for equipment and production line process validation
Support software validation and computer systems validation activities as required
Own and support CAPAs, deviation, and nonconformance investigations
Conduct risk assessments and lead failure mode and effects analysis (FMEA) activities. Ensure risks are identified, evaluated, mitigated, and documented
Develop documentation (i.e. quality plans, procedures) to ensure compliance with applicable regulations
Serve as the quality representative on Design and Development projects supporting completion of DHF documentation
Perform internal QMS/process audits and support external audits (i.e. ISO 9001, ISO 13485, FDA) to ensure compliance with quality and regulatory requirements
Support supplier quality evaluations and monitoring (audits, SCAR and other)
Participate in change management activities
Perform data analysis, KPI monitoring, identify trends and opportunities for improvement
Develop PCPs and support production lines as needed