Quality Engineer

Position Overview This position is responsible for supporting Quality processes and systems compliant to FDA regulations and ISO requirements related to the sale, manufacture, service and distribution of Hearing Instruments and related accessories.

Essential Functions (Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.) :

Develop and maintain quality system related procedures.

Develop and execute training, including competence assessment, for quality-related processes and procedures

Create, review and approve Engineering and Manufacturing Change Orders Work cross-functionally to conduct root cause investigation, action planning and verification of effectiveness for CAPAWork with manufacturing, supply chain, engineering, and others to solve internal and external supplier quality issues; investigate non-conforming product and recommend disposition

Design, supervise, and perform quality methods such as failure mode effects analysis and statistical process control

Establish and maintain systems/methods to monitor incoming, in-process and shipped product quality to ensure safety and performance, identify trends and drive improvements

Communicate with local, global and corporate functions and customers, as needed, to resolve system and product quality issues, including customer complaints

Drive Quality Planning Process including FMEA (Risk Management), Control Plan and Process Audit, etc.

Establish and maintain inspection procedures based on the material/product specifications and customer requirements

Competencies (Knowledge and Skills needed for this position.):

Strong verbal and written communication skills

Problem solving skills

Detail oriented

Root cause analysis

Risk assessments

Excellent organizations skills to manage multiple priorities

Self-directed

Drive continuous improvement throughout the organization

Desired

Qualifications:

Required Education :

Bachelor’s Degree in Engineering or equivalent experience.

Experience :2+ years related work experience: (Quality Engineering, Quality Control, Quality Improvement Projects, Root Cause Analysis, CAPA) preferred.

Experience in Medical Device Manufacturing, ISO 13485, highly preferred.

Other Information:

Direct reports : N/AIndirect reports : N/AWorking Environment :
Manufacturing facility and office environment.

Physical Demands :
Sitting, standing, lifting, bending, reaching, no more than 20 lbs.

Position Type and Expected Hours of Work :
Full-time position (Monday-Friday).Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

About UsGN brings people closer through our leading intelligent hearing, audio, video, and gaming solutions. Inspired by people and driven by innovation, we deliver technology that enhance the senses of hearing and sight. We help people with hearing loss overcome real-life challenges, improve communication and collaboration for businesses, and provide great experiences for audio and gaming enthusiasts.

What We Offer We value our employees and offer competitive wages and benefits including:

Generous Benefits including PTO and Paid Holidays
401k with Company match

Paid Parental Leave & Transition Back to Work Benefits Company HSA Contributions Discounted GN Group products

We encourage you to apply

Even if you don’t match all the above-mentioned skills, we will gladly receive your application if you think you have transferrable skills. We highly value a mindset, motivation, and energy, that aligns with our core values, to not only ensure growth for you, but for your team and the wider GN organization as well.

We are committed to an inclusive recruitment process

GN welcomes applicants from all backgrounds and applicants will receive equal consideration for employment. We make life sound better by developing intelligent sound solutions that transform lives through the power of sound, enabling you to hear more, do more & be more than you ever thought possible. Our integrated headset and communications solutions assist professionals in all types of businesses in being more productive.

Our wireless headsets are designed to fit any lifestyle - from sports enthusiasts to commuters and office workers. GN operates in more than 90 countries across the world. Founded in 1869, GN has more than 7,000 employees today.

Pay Transparency Notice:

Depending on your work location, the target annual salary for this position can range from $80,000 to $95,000 /yr. In addition, you may be eligible for a discretionary bonus. Compensation for roles at GN depend on a wide array of factors including but not limited to location, role, skill set, and level of experience. To remain competitive, GN offers a competitive benefits package, including annual bonuses, health insurance, a 401(k) plan, paid time off and paid holidays.

GN…