AI summary
Quality Engineer – Data role supporting quality systems and product/process quality for hearing instruments across sale, manufacture, service, and distribution at ReSound (GN). You’ll drive CAPA, change control, risk management and quality monitoring to improve safety, performance and compliance in a medical device manufacturing environment. Standout perks include 401(k) with company match and paid parental leave/transition back.
Key skills
CAPA planning and effectiveness verificationRoot cause analysisFMEA (risk management)Statistical Process Control (SPC)Engineering & Manufacturing Change Control (ECN/MCN review/approval)ISO 13485 (medical device QMS)Quality system procedure development and maintenanceInspection procedure development (spec/customer requirements)Process audits and control plansCustomer complaint investigation/response
Pays $80,000+ (range shown as “$80,000 to $…”) plus potential discretionary bonus; aligned with typical US mid-level Quality Engineer compensation in medical device manufacturing.
You'll thrive here if you’re a detail-oriented problem solver who enjoys cross-functional medical device quality work—from risk assessments and change control to CAPA and supplier/manufacturing issue resolution.
Why apply
- 401(k) with company match
- Paid parental leave and transition back
- Annual bonuses, health insurance, PTO
Position Overview This position is responsible for supporting Quality processes
sale, manufacture, service and distribution of Hearing Instruments and related
enable individuals with disabilities to perform the essential functions.):
Develop and maintain quality system related procedures. training, including competence assessment, for quality-related processes and
procedures Create, review and approve Engineering and Manufacturing Change
planning and verification of effectiveness for CAPA Work with manufacturing,
supply chain, engineering, and others to solve internal and external supplier
quality issues; 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
Problem solving skills Detail oriented Root cause analysis Risk assessments
Bachelor’s Degree in Engineering or equivalent experience.
Control, Quality Improvement Projects, Root Cause Analysis, CAPA) preferred.
Experience in Medical Device Manufacturing, ISO 13485, highly preferred. Manufacturing facility and office environment. Expected Hours of Work: Full-time position (Monday-Friday). hearing, audio, video, and gaming solutions. 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. Paid Holidays - 401k with Company match - Paid Parental Leave & Transition Back
we will gladly receive your application if you think you have transferrable
We highly value a mindset, motivation, and energy, that aligns with our
to fit any lifestyle - from sports enthusiasts to commuters and office workers.
location, the target annual salary for this position can range from $80,000 to
$In addition, you may be eligible for a discretionary bonus.
competitive, GN offers a competitive benefits package, including annual bonuses,
health insurance, a 401(k) plan, paid time off and paid holidays. Disability Accommodation If you have a disability and you believe
submit an online application, please e-mail
of supporting applicants who have a disability that prevents them from being
able to apply online. Emails left for other purposes, such as following up on an application or
technical issues not related to a disability, will not receive a response. pioneering innovative new technologies, with consistent quality, for over 150
years to help them feel more involved, connected and in control, transforming
GN's solutions are marketed by the brands ReSound, Beltone, Interton, Jabra and
learn more about our brand, please click on the link to explore our universe of
public the financial arrangements in place between heath plans and providers.
These files are designed to be read by a computer and are intended to be
analytics companies and applications software to have access to health plan
via machine-readable files on their websites. medical provider, BCBSMN will have “Transparency in Coverage” (TiC) information
machine readable files will help with the new transparency requirements. protected veteran status and will not be discriminated against on the basis of
disability. the company’s affirmative action plan or policy statement, please email
If you have a disability and you
or to submit an online application, please e-mail
assist disabled job seekers whose disability prevents them from being able to
apply online. left for other purposes, such as following up on an application or technical
issues not related to a disability, will not receive a response.
sale, manufacture, service and distribution of Hearing Instruments and related
enable individuals with disabilities to perform the essential functions.):
Develop and maintain quality system related procedures. training, including competence assessment, for quality-related processes and
procedures Create, review and approve Engineering and Manufacturing Change
planning and verification of effectiveness for CAPA Work with manufacturing,
supply chain, engineering, and others to solve internal and external supplier
quality issues; 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
Problem solving skills Detail oriented Root cause analysis Risk assessments
Bachelor’s Degree in Engineering or equivalent experience.
Experience
2+ years related work experience: (Quality Engineering, QualityControl, Quality Improvement Projects, Root Cause Analysis, CAPA) preferred.
Experience in Medical Device Manufacturing, ISO 13485, highly preferred. Manufacturing facility and office environment. Expected Hours of Work: Full-time position (Monday-Friday). hearing, audio, video, and gaming solutions. 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. Paid Holidays - 401k with Company match - Paid Parental Leave & Transition Back
we will gladly receive your application if you think you have transferrable
We highly value a mindset, motivation, and energy, that aligns with our
to fit any lifestyle - from sports enthusiasts to commuters and office workers.
location, the target annual salary for this position can range from $80,000 to
$In addition, you may be eligible for a discretionary bonus.
competitive, GN offers a competitive benefits package, including annual bonuses,
health insurance, a 401(k) plan, paid time off and paid holidays. Disability Accommodation If you have a disability and you believe
submit an online application, please e-mail
of supporting applicants who have a disability that prevents them from being
able to apply online. Emails left for other purposes, such as following up on an application or
technical issues not related to a disability, will not receive a response. pioneering innovative new technologies, with consistent quality, for over 150
years to help them feel more involved, connected and in control, transforming
GN's solutions are marketed by the brands ReSound, Beltone, Interton, Jabra and
learn more about our brand, please click on the link to explore our universe of
public the financial arrangements in place between heath plans and providers.
These files are designed to be read by a computer and are intended to be
analytics companies and applications software to have access to health plan
via machine-readable files on their websites. medical provider, BCBSMN will have “Transparency in Coverage” (TiC) information
machine readable files will help with the new transparency requirements. protected veteran status and will not be discriminated against on the basis of
disability. the company’s affirmative action plan or policy statement, please email
If you have a disability and you
or to submit an online application, please e-mail
assist disabled job seekers whose disability prevents them from being able to
apply online. left for other purposes, such as following up on an application or technical
issues not related to a disability, will not receive a response.