Quality Engineer

ESSENTIAL DUTIES AND 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
• May 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 others)
• Participate in change management activities
• Perform data analysis and KPI monitoring to identify trends and opportunities for improvement.
• All other duties as assigned.

KEY COMPETENCIES

To perform the job successfully, an individual should demonstrate the following competencies:

• Independence - Must have the ability to work independently and be able to step outside of your comfort zone for the purposes of QMS Module development and support: proactively takes on new tasks and sees them through to completion, escalates issues/roadblocks as appropriate
• Training - Must be comfortable training other employees, including leadership teams, on newly implemented QMS modules as well as other quality-related topics
• Safety - Implement safety practices into daily workload to protect self and others
• Customer Service - Responds promptly to customer needs; responds to requests for service and assistance
• Interpersonal Skills - Able to communicate within the team and cross-functionally
• Ethics - Works with integrity and ethics; upholds organizational values
• Organizational Support - Completes tasks correctly and on time
• Planning/Organizing - Prioritizes and plans work activities; uses time efficiently
• Quality - Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; monitors own work to ensure quality and compliance
• Quantity - Meets productivity standards; completes work in a timely manner
• Attendance/Punctuality - Is consistently at work and on time
• Dependability - Follows instructions, responds to management direction, takes responsibility for own actions, and completes tasks on time or notifies the appropriate person with an alternate plan
• Oral Communication - Listens and gets clarification; responds well to questions
• Teamwork - Balances team and individual responsibilities; exhibits objectivity and openness to others' views; gives and welcomes feedback; contributes to building a positive team spirit
• Diversity - Shows respect and sensitivity for cultural differences; educates others on the value of diversity; promotes a harassment-free environment; builds a diverse workforce

EDUCATION AND QUALIFICATIONS

• Bachelor’s degree (engineering, science, or a related field preferred) or commensurate offsetting experience in quality engineering.

EXPERIENCE

• 5+ years of hands-on experience in medical device quality engineering
• Experience with QMS development and implementation is a plus
• Experience with FDA-regulated products and ISO 13485 certified QMS
• Experience in product development, including implementing appropriate controls
• Working knowledge of statistics is required, with 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/ophthalmic is a plus
• Proficiency with Minitab, MS Outlook, MS Word, and MS Excel
• Experience with ISO 14971 risk management is a plus

DEMONSTRATED ABILITIES

• 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
• 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

WORK ENVIRONMENT

Environmental: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Physical: While performing the duties of this job, the employee must occasionally lift and/or move up to 30 pounds.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is regularly required to sit and to use hands to grasp and manipulate. The job requires working near moving mechanical parts, fumes or airborne particles, UV rays, and toxic or caustic chemicals. The work environment noise level is usually moderate.

SAFETY REQUIREMENTS

• Basic understanding of the Injury and Illness Prevention Program and the Hazard Communication Program
• Closed-toe shoes with heel support may be required where needed
• While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts. The noise level in the work environment may require P.P.E.
• Safety glasses and long-sleeve shirts may be required where needed

Driven by a passion for partnership as well as innovation, HOYA has been a partner to Eye Care Professionals for over 75 years, enabling them to give people the greatest gift, the gift of vision. We provide Eye Care Professionals with the lenses, consultation solutions and other services that help them to develop their practice while changing the way people see the world. We see them as visionaries, and everything we do is for them. Founded in Japan in 1941, today, HOYA has a presence in over 80 countries across the globe.

HOYA Group: Founded in 1941 in Tokyo, Japan, HOYA Corporation is a global technology and med-tech company and a leading supplier of innovative high-tech and medical products. HOYA’s divisions and business units research and develop products utilized in the healthcare and information technology fields. In the healthcare field, we provide medical device products such as eyeglasses, medical endoscopes, contact and intraocular lenses, orthopedic implants, surgical/therapeutic devices and medical device reprocessing and disinfection solutions. In the information technology field, we provide products such as optical lenses, photomasks and blanks used in the manufacturing process for semiconductor and LCD/OLED devices, text-to-speech, human resources and other software solutions and critical components for the mass memory and cloud storage industries. With over 150 offices and subsidiaries worldwide, HOYA currently employs a multinational workforce of 37,000 people.

HOYA Vision Care: As a global leader in optical technology, HOYA Vision Care is dedicated to providing innovative vision care solutions for every stage of a patient’s life. A steadfast partner to Eye Care Professionals around the world, it stands at the forefront of optical excellence. With a global presence, consisting of 43 laboratories and a growing team of 20,000 employees, HOYA Vision Care delivers innovative lenses and other vision care solutions to millions of people in 110 countries.

We focus on a better tomorrow, today. You can become part of our story. HOYA Vision Care is the place where you can act according to your strengths and evolve according to your aspirations. It’s a place where you can shape the way you work, guided by our CLEAR Values, and empowered by generations of expertise. You can get involved in our sustainability initiatives and choose to become a One Vision ambassador. You can give back the gift of sight to people all over the world by deciding to work with us.

We welcome people who challenge us to become better, who share our sense of purpose and who embrace growth so that our vision and mission align. We invite you to find out more, and together we can continue to provide vision for a lifetime.