Quality Engineer jobs at Getinge Usa, Inc.

Aetrex is the global leader in foot scanning technology. Our very latest scanner, Albert, was created over several years by a team of leading engineers and programmers and represents a major advance in technology for consumers and retailers alike. This revolutionary 3D system joins Aetrex's fleet of renown foot scanners, including Gaitway, Nova and Eclipse. The Aetrex technology development team consists of a diverse group of programmers that work together to create exciting User Interface and Experience for our customers. For over 20 years we have developed software for scanners and mobile devices that have helped millions of people experience relief from unnecessary foot pain. AlbertOS is a new, groundbreaking operating system that runs the Albert and Gaitway scanning devices and can be easily operated using simple voice or touch commands. Albert captures unmatched data and information about feet, enabling consumers to make more educated buying decisions when it comes to footwear and orthotic purchases. We're hiring a Software Quality & Operations Efficiency Engineer to join our team! This dual-focused role requires an individual who can tackle the complete automation of our software testing suite and improve the operational efficiency of the software in the field. The ideal candidate will bridge the gap between technical support and quality assurance. Key Responsibilities: I. Software Quality & Automation Framework Development Design, build, and maintain robust, scalable test automation frameworks. Develop and execute automated tests for both UI and APIs (e.g., Selenium WebDriver and Postman), integrating these into Testing frameworks. Participate in new software release testing cycles, providing critical technical feedback to the development team. II. Operational Efficiency & Tooling Develop, maintain, and execute powerful scripts (e.g., PowerShell, Bash) to automate routine system diagnostics, support tasks, and operational workflows. Create small internal tools using coding experience (Python experience is a major asset) to enhance diagnostic capabilities and streamline support processes. Document all testing, support, and automation processes clearly using tools like Confluence and manage workflow in Jira. III. Technical Support Resolve technical issues, providing effective, timely support to customers via phone, email, and remote sessions, with a strong emphasis on the Windows OS environment. Utilize SQL and database knowledge (including MySql) to perform complex data querying and analysis, ensuring data integrity during troubleshooting. Monitor and troubleshoot applications deployed on AWS cloud services, demonstrating foundational knowledge of EC2, S3, and CloudWatch. Requirements: 5+ years in Software Testing, Operations Monitoring, Technical Support, Help Desk, Quality Assurance or comparable technical role. Hands-on experience with a frontend testing tool (Selenium Web Driver/Playwright/TestSprite, etc) and a backend testing tool (Postman/SoapUI, etc). Strong proficiency in scripting (e.g., PowerShell, Bash). PowerShell is highly preferred. Solid understanding and hands-on experience with SQL for querying and troubleshooting. In-depth knowledge of Windows Operating Systems and associated configurations/troubleshooting. Familiarity with AWS Cloud Services: Practical experience troubleshooting or monitoring applications deployed on Amazon Web Services (AWS), including foundational knowledge of services like EC2, S3, or CloudWatch. Demonstrated ability to manage testing protocols and improve operations efficiency in a software environment. Excellent organizational skills, including the ability to generate clear reports and diligently manage follow-up tasks. Experience with a programming language; Python experience is a major asset.

We're a “safety first high performance” culture driven by a zero waste and zero defect mentality set out to enrich the lives of humans everywhere. As a leading vitamin and food supplement manufacturer, we carry on the legacy of our Founder who led us to reshape the category. We have grown our passionate Piping Rock Family as we've grown our business. We are growing quickly, join the Piping Rock family and grow your career. As a Process Engineer, you'll be responsible for equipment re-design while implementing, controlling, and optimizing packaging/manufacturing processes and machinery to achieve organizational targets. You'll work hand in hand with Production and Engineering to help improve standards that enable high performing production processes in our facility. Additional responsibilities include defining equipment standards, leading process and benchmarking and reapplication, and building capability within teams to do technical troubleshooting and process improvement and understanding the Piping Rock Continuous Excellence program and the respective tools. Responsibilities: Analyze production loss data to identify and prioritize projects to be executed in factory's continuous improvement plan and develop technical mastery of the core production processes, driven by bottleneck/high losses. Lead v-curve analysis and balanced line flow studies and identify debottlenecking projects. Initiate, lead, and modify process/improvements that will increase throughput, reduce scrap, improve quality, and eliminate losses. Implement LEAN manufacturing methods. Drive and mobilize resources to conduct problem solving on systems or equipment through failure modes & effects analysis (FMEA) and other Six Sigma methodology. Develop productivity standards, collect data to publish KPI and OEE reports. Participate in planning, commissioning, and startup of new equipment/processes. Creating and improving standards that enable sustainability of high preforming production processes and supporting training programs that develop high performing operators and technicians and. Collaborating with technical experts, other functions, and other factories to create and replicate optimal solutions/best practices. Establish operating parameters for each equipment by product to obtain reliable and efficient production Responsible for working directly on the manufacturing lines and assisting mechanics during repairs to understand the process workflow. Work schedule flexibility to overlap with other shifts as needed. Other duties as assigned. Qualifications: Bachelor's degree in an engineering field, preferably Industrial and Systems Engineering 3+ years of project/ process management experience in a manufacturing, or packaging environment. Or Associates degree in a technical field. 7+ years of project/ process management experience in a manufacturing, or packaging environment. Preferred Skills: Six Sigma or Lean certification. Experience with process automation and control systems. GMP environment a plus Must be able to lift 30lbs Must be able to stand for 8 hours Must be able to work in a physically challenging environment. We proudly offer: Medical, Dental, Vision, 401K with Company Match, Pet insurance and more! We reward the hard work of our team members with fun and exciting company events, Summer Picnic, Festive Packages, Holiday Celebrations, and associate referral bonuses! Founded in 2011, Piping Rock Health Products has gone on to win Long Island's Top Workplaces Award 6 years in a row & securing the spot as Top Supplement Manufacturing Company 2024 by Food Business Review! Supported by a group of vitamin visionaries with over 40 years of industry experience and a carefully curated team of talented associates. Piping Rock is a global vitamin and supplement manufacturer with an unwavering commitment to creating quality wellness products. We believe that family always comes first, and that the dedication of our associates is the key ingredient to our success. We are drug free workplace, regulated by the FDA, required to follow Federal Guidelines; therefore in order to start as well as maintain employment, you must be able to successfully clear drug screening processes, which include testing for all illegal substances per Federal Guidelines. Piping Rock Health Products, INC is an Equal Opportunity Employer.

A bit about this role: The IP Quality Program Manager for Inpatient is a high-impact, hands-on leader responsible for driving clinical quality, regulatory compliance, and operational efficiency across the Utilization Management (UM) department. This role combines advanced UM expertise, AI/LLM integration, and data-driven decision-making to transform clinical review, audit, and workflow operations. The Program Manager will oversee all Quality activities within the Inpatient Team, lead AI-powered audit initiatives, and ensure all IP processes meet Regulatory and CMS Regulations. This is a fast-paced, high-change environment requiring someone who thrives on operational challenges, can manage multiple priorities simultaneously, and is comfortable leading innovation at the intersection of clinical operations and technology Your Responsibilities and Impact will include: Lead New Hire Onboarding & Development - Build and maintain standardized training, assess learning milestones, and provide targeted re-education to support progression into more complex clinical reviews. Monitor & Improve OD Compliance - Partner with Compliance, A&G, and UM leadership to track OD timeliness, accuracy, and overturns; use insights to mitigate risk and drive continuous improvement. Integrate CMS Regulatory Updates - Stay current on OD-related CMS changes and embed updates into SOPs, training materials, and clinical review practices; proactively re-educate staff. Drive Clinical Decision Quality - Evaluate clinical decision-making for accuracy, consistency, and adherence to evidence-based criteria; use audits to identify trends and direct interventions. Lead Remediation & Quality Improvement - Develop and deliver corrective action plans, workflow refinements, and policy updates based on error patterns or emerging risks. Provide SME Guidance & Real-Time Coaching - Serve as a clinical and operational resource; support staff with real-time problem solving and reinforce best practices. Deliver Ongoing Education & IRR - Conduct in-services, case studies, and cross-functional learning sessions; manage IRR reviews and implement training based on results; maintain a comprehensive learning library. Maintain Clinical Tools & SOP Alignment - Curate job aids, decision tools, and supplemental materials; support annual SOP reviews to ensure accuracy, consistency, and compliance. Support Team Operations & Cross-Functional Work - Participate in weekly assignment planning, team meetings, committees, workflow changes, and partner-department initiatives; respond to interdepartmental questions. Advance AI/LLM Adoption in Clinical Practice - Utilize AI/LLM models to strengthen decision quality and predictive analytics; implement AI-driven tools; train staff on effective use of AI in clinical workflows. Required skills and experience: Strong clinical expertise with an unrestricted RN license and 5+ years of nursing experience, including at least 4 years in health plan Utilization Management; prior provider-side clinical experience preferred. Demonstrated leadership, collaboration, and coaching abilities, with experience training or teaching nurses/clinicians in complex clinical and regulatory topics. Advanced analytical, strategic thinking, and problem-solving skills, with the ability to navigate complexity and balance multiple priorities in a fast-paced or startup environment. In-depth knowledge of Medicare Advantage, CMS guidelines, and regulations governing claims, appeals, and grievances, with proven ability to apply compliance requirements in daily operations. Experience with AI/LLM technologies, including applying AI tools to clinical decision-making, operational workflows, or reviewer support. Member- and colleague-centric mindset, demonstrating empathy, service orientation, and commitment to high-quality, compliant care delivery. Desired skills and experience: Certified InterQual Trainer and/or Certified Coder #LI-DS1 #LI-Remote Salary Range: $80,000-$120,000 / year The pay range listed for this position is the range the organization reasonably and in good faith expects to pay for this position at the time of the posting. Once the interview process begins, your talent partner will provide additional information on the compensation for the role, along with additional information on our total rewards package. The actual base salary offered will depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. Our Total Rewards package includes: Employer sponsored health, dental and vision plan with low or no premium Generous paid time off $100 monthly mobile or internet stipend Stock options for all employees Bonus eligibility for all roles excluding Director and above; Commission eligibility for Sales roles Parental leave program 401K program And more.... *Our total rewards package is for full time employees only. Intern and Contract positions are not eligible. Healthcare equality is at the center of Devoted's mission to treat our members like family. We are committed to a diverse and vibrant workforce. At Devoted Health, we're on a mission to dramatically improve the health and well-being of older Americans by caring for every person like family. That's why we're gathering smart, diverse, and big-hearted people to create a new kind of all-in-one healthcare company - one that combines compassion, health insurance, clinical care, service, and technology - to deliver a complete and integrated healthcare solution that delivers high quality care that everyone would want for someone they love. Founded in 2017, we've grown fast and now serve members across the United States. And we've just started. So join us on this mission! Devoted is an equal opportunity employer. We are committed to a safe and supportive work environment in which all employees have the opportunity to participate and contribute to the success of the business. We value diversity and collaboration. Individuals are respected for their skills, experience, and unique perspectives. This commitment is embodied in Devoted's Code of Conduct, our company values and the way we do business. As an Equal Opportunity Employer, the Company does not discriminate on the basis of race, color, religion, sex, pregnancy status, marital status, national origin, disability, age, sexual orientation, veteran status, genetic information, gender identity, gender expression, or any other factor prohibited by law. Our management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities and general treatment during employment.

011230 CA-Provider Engagement & Performance The Program Manager, in collaboration with the Sr Director of Delegation Partnerships and Performance, is responsible for advancing provider quality performance across CCA's contracted network, with a focus on value-based arrangements and network-wide engagement strategies. The program manager is responsible for managing and implementing key population health and network quality initiatives to achieve high performance on CCA's Population Health goals; including Medicare Star measures, Medicaid-Medicare Plan withhold measures, quality performance metrics incorporated into other CCA contracts, health equity, Culturally and Linguistically Appropriate Services, Consumer Assessment of Healthcare Providers and Systems (CAHPS), and social determinants of health (SDOH) measures. The Program Manager will work collaboratively with our provider network and Quality teams to identify quality metrics that align contracting efforts for efficiency and effectives with alternative payment models. The Program This role serves as a critical bridge between Provider Engagement, Network Performance, Analytics, Clinical and Quality Teams to drive improvement in clinical outcomes, health equity, and member and provider experience. **Supervision Exercised** + No direct reports currently; however, one to three program consultants with future expansion. **Essential Duties & Responsibilities:** **Provider Quality Performance and Value-Based Care** + Lead implementation and monitoring of quality initiatives tied to value-based payment programs and contractual performance metrics. + Partner with Provider Engagement, Network, Clinical and Quality teams to evaluate provider performance, identify opportunities for improvement, and facilitate data-driven action plans. + Collaborate with Contracting, Quality Analytics, and Population Health to align provider quality measures with value-based contracts and incentive programs. + Translate quality performance data into actionable insights and communicate findings to provider partners to drive improvement. + Support the development and oversight of provider pay-for-performance programs, including metric tracking, financial reconciliation, and performance reporting. **Health Equity and CLAS Integration** + Partner with the Health Equity team to incorporate CLAS (Culturally and Linguistically Appropriate Services) standards into provider education and engagement activities. + Lead or support the development and dissemination of provider-facing resources that advance equitable care delivery. + Coordinate provider training and communication initiatives focused on social drivers of health, cultural competence, and equity-focused performance improvement. **CAHPS Strategy and Performance** + Oversee implementation of provider-focused initiatives that support CAHPS performance improvement. + Analyze CAHPS results to identify trends and collaborate with Provider Network, Clinical and Quality teams to address performance gaps. + Develop and disseminate provider education and best practices to improve member satisfaction with access, communication, and care coordination. + Track and report provider performance metrics related to CAHPS domains such as Getting Needed Care, Getting Care Quickly, Rating of Health Care, and Customer Service. + Collaborates with Communications to design provider materials and newsletters reinforcing CAHPS-related expectations and improvement goals. + Partners with network leadership to recognize high-performing providers and share improvement strategies. **Provider Education and Engagement** + Manage the design, scheduling, and delivery of provider quality education, including webinars, learning sessions, and quality performance updates in collaboration with Quality team. + Develop materials and presentations that clearly communicate quality goals, contractual expectations, and best practices to the provider network. + Serve as a trusted liaison to provider partners, responding to quality-related inquiries and facilitating collaborative discussions on improvement opportunities. **Performance Reporting & Data Management** + Partner with Quality Analytics and Business Intelligence to ensure timely, accurate, and meaningful quality performance reporting to internal teams and providers. + Monitor performance trends and support the creation of dashboards, summaries, and progress reports for internal and external audiences. + Maintain documentation, SOPs, and reporting schedules to support consistent quality operations. **Cross-Functional Collaboration & Strategic Support** + Collaborate closely with Provider Engagement, Contracting, Quality, and Clinical to ensure alignment on provider quality goals. + Participate in cross-functional workgroups focused on quality improvement, network performance, and member and provider experience. + Support strategic initiatives that promote continuous improvement and operational efficiency across the provider network. **Working Conditions** + Remote or hybrid working conditions. Position requires occasional travel in Massachusetts and the surrounding area. **Required Education** : + Bachelor's degree in healthcare administration, public health, business or health care related field **Desired Education:** + Master's degree + Certified Professional in Healthcare Quality (CPHQ) or equivalent certification **Required Experience:** + 5-7 years of experience in healthcare quality improvement, provider network performance and management, population health, or related area + Demonstrated experience interpreting and applying quality measures (HEDIS, CAHPS, HOS) and value-based contract performance metrics + Experience with Medicare Advantage, Medicaid; and dually eligible populations **Desired Experience** + Experience managing or supporting pay-for-performance or value-based care programs. + Experience leading provider education or training sessions. + Exposure to health equity initiatives and/or CLAS standards integration in provider settings. **Required Knowledge, Skills & Abilities:** + Strong understanding of provider quality performance frameworks and value-based care principles. + Working knowledge of claims data, quality measurement, and performance incentive methodologies. + Excellent verbal and written communication skills, including the ability to synthesize and present data effectively to providers and internal stakeholders. + Strong relationship management and interpersonal skills; ability to engage diverse provider partners diplomatically. + Proficiency with Microsoft Office Suite (Excel, PowerPoint, Word) and comfort working with dashboards and analytics tools. + Proven project management skills and ability to manage multiple priorities and deadlines. + Self-directed, detail-oriented, and able to work effectively in a fast-paced, matrixed environment. **Desired Knowledge, Skills & Abilities:** + Familiarity with quality analytics platforms, provider portals, or data visualization tools. + Working knowledge of health plan claims and payment policies, including provider reimbursement methodologies. + Experience applying CLAS standards or health equity frameworks within provider engagement or quality improvement initiatives. **Language(s)** + English **Compensation Range/Target: $99,600 - $149,400** Commonwealth Care Alliance takes into consideration a combination of a candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required for the role, and other external and internal data when establishing a salary level. In addition to base compensation, you may qualify for a bonus tied to company and individual performance. We are highly invested in every employee's total well-being and offer a substantial and comprehensive total rewards package. EEO is The Law Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled Please note employment with CCA is contingent upon acceptable professional references, a background check (including Mass CORI, employment, education, criminal check, and driving record, (if applicable)), an OIG Report and verification of a valid MA/RN license (if applicable). Commonwealth Care Alliance is an equal opportunity employer. Applicants are considered for positions without regard to veteran status, uniformed service member status, race, color, religion, sex, national origin, age, physical or mental disability, genetic information or any other category protected by applicable federal, state or local laws.

011230 CA-Provider Engagement & Performance The Program Manager, in collaboration with the Sr Director of Delegation Partnerships and Performance, is responsible for advancing provider quality performance across CCA's contracted network, with a focus on value-based arrangements and network-wide engagement strategies. The program manager is responsible for managing and implementing key population health and network quality initiatives to achieve high performance on CCA's Population Health goals; including Medicare Star measures, Medicaid-Medicare Plan withhold measures, quality performance metrics incorporated into other CCA contracts, health equity, Culturally and Linguistically Appropriate Services, Consumer Assessment of Healthcare Providers and Systems (CAHPS), and social determinants of health (SDOH) measures. The Program Manager will work collaboratively with our provider network and Quality teams to identify quality metrics that align contracting efforts for efficiency and effectives with alternative payment models. The Program This role serves as a critical bridge between Provider Engagement, Network Performance, Analytics, Clinical and Quality Teams to drive improvement in clinical outcomes, health equity, and member and provider experience. Supervision Exercised No direct reports currently; however, one to three program consultants with future expansion. Essential Duties & Responsibilities: Provider Quality Performance and Value-Based Care Lead implementation and monitoring of quality initiatives tied to value-based payment programs and contractual performance metrics. Partner with Provider Engagement, Network, Clinical and Quality teams to evaluate provider performance, identify opportunities for improvement, and facilitate data-driven action plans. Collaborate with Contracting, Quality Analytics, and Population Health to align provider quality measures with value-based contracts and incentive programs. Translate quality performance data into actionable insights and communicate findings to provider partners to drive improvement. Support the development and oversight of provider pay-for-performance programs, including metric tracking, financial reconciliation, and performance reporting. Health Equity and CLAS Integration Partner with the Health Equity team to incorporate CLAS (Culturally and Linguistically Appropriate Services) standards into provider education and engagement activities. Lead or support the development and dissemination of provider-facing resources that advance equitable care delivery. Coordinate provider training and communication initiatives focused on social drivers of health, cultural competence, and equity-focused performance improvement. CAHPS Strategy and Performance Oversee implementation of provider-focused initiatives that support CAHPS performance improvement. Analyze CAHPS results to identify trends and collaborate with Provider Network, Clinical and Quality teams to address performance gaps. Develop and disseminate provider education and best practices to improve member satisfaction with access, communication, and care coordination. Track and report provider performance metrics related to CAHPS domains such as Getting Needed Care, Getting Care Quickly, Rating of Health Care, and Customer Service. Collaborates with Communications to design provider materials and newsletters reinforcing CAHPS-related expectations and improvement goals. Partners with network leadership to recognize high-performing providers and share improvement strategies. Provider Education and Engagement Manage the design, scheduling, and delivery of provider quality education, including webinars, learning sessions, and quality performance updates in collaboration with Quality team. Develop materials and presentations that clearly communicate quality goals, contractual expectations, and best practices to the provider network. Serve as a trusted liaison to provider partners, responding to quality-related inquiries and facilitating collaborative discussions on improvement opportunities. Performance Reporting & Data Management Partner with Quality Analytics and Business Intelligence to ensure timely, accurate, and meaningful quality performance reporting to internal teams and providers. Monitor performance trends and support the creation of dashboards, summaries, and progress reports for internal and external audiences. Maintain documentation, SOPs, and reporting schedules to support consistent quality operations. Cross-Functional Collaboration & Strategic Support Collaborate closely with Provider Engagement, Contracting, Quality, and Clinical to ensure alignment on provider quality goals. Participate in cross-functional workgroups focused on quality improvement, network performance, and member and provider experience. Support strategic initiatives that promote continuous improvement and operational efficiency across the provider network. Working Conditions Remote or hybrid working conditions. Position requires occasional travel in Massachusetts and the surrounding area. Required Education: Bachelor's degree in healthcare administration, public health, business or health care related field Desired Education: Master's degree Certified Professional in Healthcare Quality (CPHQ) or equivalent certification Required Experience: 5-7 years of experience in healthcare quality improvement, provider network performance and management, population health, or related area Demonstrated experience interpreting and applying quality measures (HEDIS, CAHPS, HOS) and value-based contract performance metrics Experience with Medicare Advantage, Medicaid; and dually eligible populations Desired Experience Experience managing or supporting pay-for-performance or value-based care programs. Experience leading provider education or training sessions. Exposure to health equity initiatives and/or CLAS standards integration in provider settings. Required Knowledge, Skills & Abilities: Strong understanding of provider quality performance frameworks and value-based care principles. Working knowledge of claims data, quality measurement, and performance incentive methodologies. Excellent verbal and written communication skills, including the ability to synthesize and present data effectively to providers and internal stakeholders. Strong relationship management and interpersonal skills; ability to engage diverse provider partners diplomatically. Proficiency with Microsoft Office Suite (Excel, PowerPoint, Word) and comfort working with dashboards and analytics tools. Proven project management skills and ability to manage multiple priorities and deadlines. Self-directed, detail-oriented, and able to work effectively in a fast-paced, matrixed environment. Desired Knowledge, Skills & Abilities: Familiarity with quality analytics platforms, provider portals, or data visualization tools. Working knowledge of health plan claims and payment policies, including provider reimbursement methodologies. Experience applying CLAS standards or health equity frameworks within provider engagement or quality improvement initiatives. Language(s) English Compensation Range/Target: $99,600 - $149,400 Commonwealth Care Alliance takes into consideration a combination of a candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required for the role, and other external and internal data when establishing a salary level. In addition to base compensation, you may qualify for a bonus tied to company and individual performance. We are highly invested in every employee's total well-being and offer a substantial and comprehensive total rewards package.

Marlborough, MA, United States Newark, DE, United States Are you passionate about ensuring the quality and reliability of life-saving medical devices? At Hologic, we are seeking a **Senior Product Quality Engineer** to provide engineering support for on-market medical devices. In this role, you will lead complaint investigations, perform root cause analyses, and drive the implementation of corrective and preventive actions to improve product performance. Collaborating with cross-functional teams, you'll contribute to product design, process improvements, and regulatory compliance while making a meaningful impact on patient safety and satisfaction. If you're a proactive problem-solver with a strong background in quality engineering, we encourage you to apply! **Knowledge:** + Strong understanding of FDA Quality System Regulations, including Design Control requirements, ISO 13485, EU Medical Device Regulation, and ISO 14971 (Risk Management). + Familiarity with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP). + Knowledge of root cause analysis tools and risk-based decision-making processes. + Preferred: Familiarity with test method validation, statistical methods, and standards related to reliability, electrical safety, sterilization, packaging, and biocompatibility. **Skills:** + Proven ability to lead complaint investigations, root cause analyses, and CAPA activities to resolve quality issues and improve product performance. + Strong data analysis and trending skills to identify patterns, assess risks, and recommend mitigations. + Ability to manage and implement design or process changes, including testing, documentation, and change control. + Effective communication and presentation skills to articulate findings, root causes, and recommendations to stakeholders and leadership. + Ability to collaborate with cross-functional teams, including Operations, Engineering, and R&D, to drive improvements in product design and manufacturing processes. + Preferred: Experience with statistical tools, design of experiments (DOE), and verification/validation requirements for regulated products. **Behaviors:** + Detail-oriented and compliance-focused, ensuring adherence to regulatory standards and quality system requirements. + Proactive and results-driven, with a strong sense of ownership for deliverables and outcomes. + Collaborative and team-oriented, building productive relationships across functions to drive quality improvements. + Customer-focused, with a commitment to addressing field quality issues and ensuring timely resolution. + Continuous improvement mindset, actively identifying opportunities to enhance processes and product quality. **Experience:** + Bachelor's degree in Engineering (Mechanical, Electrical, Biomedical, or related discipline) required. + **5+ years** of experience with a Bachelor's degree in Mechanical, Biomedical, Biomechanical, or Electrical Engineering. + **1-3 years** of experience with a Master's degree, or **0-1 year** with a PhD in a related field. + Experience in an FDA-regulated industry preferred. + Hands-on experience in root cause analysis, complaint investigations, and product development or R&D is beneficial. **Why join Hologic?** We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. The annualized base salary range for this role is $97,600-$152,700 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand. **Agency and Third-Party Recruiter Notice** _Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered._ **_Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans._** \#LI-NT1

Marlborough, MA, United States Newark, DE, United States Are you passionate about ensuring the quality and reliability of life-saving medical devices? At Hologic, we are seeking a **Senior Product Quality Engineer** to provide engineering support for on-market medical devices. In this role, you will lead complaint investigations, perform root cause analyses, and drive the implementation of corrective and preventive actions to improve product performance. Collaborating with cross-functional teams, you'll contribute to product design, process improvements, and regulatory compliance while making a meaningful impact on patient safety and satisfaction. If you're a proactive problem-solver with a strong background in quality engineering, we encourage you to apply! **Knowledge:** + Strong understanding of FDA Quality System Regulations, including Design Control requirements, ISO 13485, EU Medical Device Regulation, and ISO 14971 (Risk Management). + Familiarity with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP). + Knowledge of root cause analysis tools and risk-based decision-making processes. + Preferred: Familiarity with test method validation, statistical methods, and standards related to reliability, electrical safety, sterilization, packaging, and biocompatibility. **Skills:** + Proven ability to lead complaint investigations, root cause analyses, and CAPA activities to resolve quality issues and improve product performance. + Strong data analysis and trending skills to identify patterns, assess risks, and recommend mitigations. + Ability to manage and implement design or process changes, including testing, documentation, and change control. + Effective communication and presentation skills to articulate findings, root causes, and recommendations to stakeholders and leadership. + Ability to collaborate with cross-functional teams, including Operations, Engineering, and R&D, to drive improvements in product design and manufacturing processes. + Preferred: Experience with statistical tools, design of experiments (DOE), and verification/validation requirements for regulated products. **Behaviors:** + Detail-oriented and compliance-focused, ensuring adherence to regulatory standards and quality system requirements. + Proactive and results-driven, with a strong sense of ownership for deliverables and outcomes. + Collaborative and team-oriented, building productive relationships across functions to drive quality improvements. + Customer-focused, with a commitment to addressing field quality issues and ensuring timely resolution. + Continuous improvement mindset, actively identifying opportunities to enhance processes and product quality. **Experience:** + Bachelor's degree in Engineering (Mechanical, Electrical, Biomedical, or related discipline) required. + **5+ years** of experience with a Bachelor's degree in Mechanical, Biomedical, Biomechanical, or Electrical Engineering. + **1-3 years** of experience with a Master's degree, or **0-1 year** with a PhD in a related field. + Experience in an FDA-regulated industry preferred. + Hands-on experience in root cause analysis, complaint investigations, and product development or R&D is beneficial. **Why join Hologic?** We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. The annualized base salary range for this role is $97,600-$152,700 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand. **Agency and Third-Party Recruiter Notice** _Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered._ **_Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans._** \#LI-NT1

Marlborough, MA, United States Are you passionate about ensuring the quality and safety of medical devices? At Hologic, we are seeking a Quality Engineer to provide engineering support for on-market medical devices. In this role, you'll lead investigations into post-market feedback and complaints, conduct root cause analyses, and implement corrective or preventive actions to ensure our products meet the highest standards of quality and safety. Collaborating with cross-functional teams, you'll drive product and process improvements while making a meaningful impact on the lives of patients worldwide. If you're a proactive problem-solver with experience in quality, risk management, and engineering, we'd love to have you on our team! **Knowledge:** + Strong understanding of FDA Quality System Regulations, particularly Design Control requirements. + In-depth knowledge of ISO 13485, EU Medical Device Regulation, and ISO 14971 (Risk Management). + Familiarity with test method validation, root cause failure analysis, and statistical methods. + Knowledge of system-level requirements for complex medical devices, including software, electromechanical, and hardware components. + Awareness of reliability, electrical safety, sterilization, packaging, and biocompatibility standards. **Skills:** + Proven ability to lead cross-functional teams in conducting investigations and implementing corrective and preventive actions (CAPAs). + Strong analytical skills to prioritize complaints and investigations based on risk, data analysis, and strategic impact. + Excellent project management skills, including implementing design or process changes, performing testing, and managing change control documentation. + Ability to perform independent health risk assessments and present findings to leadership. + Effective communication skills to present product quality metrics, root cause analyses, and recommended actions to internal stakeholders and leadership. + Strong ability to assess and review written product and project documentation for compliance. + Preferred: Experience with verification and validation requirements, design of experiments, and requirements analysis for regulated products. **Behaviors:** + Detail-oriented and committed to maintaining the highest standards of quality and regulatory compliance. + Proactive and decisive, with the ability to independently prioritize tasks and resolve conflicts. + Collaborative and team-oriented, with a focus on fostering productive working relationships across functions. + Problem-solving mindset, focused on identifying root causes and driving effective solutions. + Customer-focused, with a commitment to addressing product quality issues and ensuring customer satisfaction. + Driven by continuous improvement, with a desire to optimize processes and enhance product quality. **Experience:** + **5+ years** of experience in engineering, preferably in a regulated industry such as medical devices. + Hands-on experience with root cause analysis, product development, or R&D. + Beneficial experience includes supporting complex medical devices (e.g., software, electromechanical systems) at the system level. **Education:** + Bachelor's degree in Engineering (Mechanical, Electrical, Biomedical, or related field). **Why join Hologic?** We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. The annualized base salary range for this role is $97,600-$152,700 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand. **Agency and Third-Party Recruiter Notice** _Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered._ **_Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans._** \#LI-NT1

Are you passionate about ensuring the quality and reliability of life-saving medical devices? At Hologic, we are seeking a Senior Product Quality Engineer to provide engineering support for on-market medical devices. In this role, you will lead complaint investigations, perform root cause analyses, and drive the implementation of corrective and preventive actions to improve product performance. Collaborating with cross-functional teams, you'll contribute to product design, process improvements, and regulatory compliance while making a meaningful impact on patient safety and satisfaction. If you're a proactive problem-solver with a strong background in quality engineering, we encourage you to apply! Knowledge: Strong understanding of FDA Quality System Regulations, including Design Control requirements, ISO 13485, EU Medical Device Regulation, and ISO 14971 (Risk Management). Familiarity with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP). Knowledge of root cause analysis tools and risk-based decision-making processes. Preferred: Familiarity with test method validation, statistical methods, and standards related to reliability, electrical safety, sterilization, packaging, and biocompatibility. Skills: Proven ability to lead complaint investigations, root cause analyses, and CAPA activities to resolve quality issues and improve product performance. Strong data analysis and trending skills to identify patterns, assess risks, and recommend mitigations. Ability to manage and implement design or process changes, including testing, documentation, and change control. Effective communication and presentation skills to articulate findings, root causes, and recommendations to stakeholders and leadership. Ability to collaborate with cross-functional teams, including Operations, Engineering, and R&D, to drive improvements in product design and manufacturing processes. Preferred: Experience with statistical tools, design of experiments (DOE), and verification/validation requirements for regulated products. Behaviors: Detail-oriented and compliance-focused, ensuring adherence to regulatory standards and quality system requirements. Proactive and results-driven, with a strong sense of ownership for deliverables and outcomes. Collaborative and team-oriented, building productive relationships across functions to drive quality improvements. Customer-focused, with a commitment to addressing field quality issues and ensuring timely resolution. Continuous improvement mindset, actively identifying opportunities to enhance processes and product quality. Experience: Bachelor's degree in Engineering (Mechanical, Electrical, Biomedical, or related discipline) required. 5+ years of experience with a Bachelor's degree in Mechanical, Biomedical, Biomechanical, or Electrical Engineering. 1-3 years of experience with a Master's degree, or 0-1 year with a PhD in a related field. Experience in an FDA-regulated industry preferred. Hands-on experience in root cause analysis, complaint investigations, and product development or R&D is beneficial. Why join Hologic? We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. The annualized base salary range for this role is $97,600-$152,700 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand. Agency and Third-Party Recruiter Notice Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans. #LI-NT1

Are you passionate about ensuring the quality and safety of medical devices? At Hologic, we are seeking a Quality Engineer to provide engineering support for on-market medical devices. In this role, you'll lead investigations into post-market feedback and complaints, conduct root cause analyses, and implement corrective or preventive actions to ensure our products meet the highest standards of quality and safety. Collaborating with cross-functional teams, you'll drive product and process improvements while making a meaningful impact on the lives of patients worldwide. If you're a proactive problem-solver with experience in quality, risk management, and engineering, we'd love to have you on our team! Knowledge: Strong understanding of FDA Quality System Regulations, particularly Design Control requirements. In-depth knowledge of ISO 13485, EU Medical Device Regulation, and ISO 14971 (Risk Management). Familiarity with test method validation, root cause failure analysis, and statistical methods. Knowledge of system-level requirements for complex medical devices, including software, electromechanical, and hardware components. Awareness of reliability, electrical safety, sterilization, packaging, and biocompatibility standards. Skills: Proven ability to lead cross-functional teams in conducting investigations and implementing corrective and preventive actions (CAPAs). Strong analytical skills to prioritize complaints and investigations based on risk, data analysis, and strategic impact. Excellent project management skills, including implementing design or process changes, performing testing, and managing change control documentation. Ability to perform independent health risk assessments and present findings to leadership. Effective communication skills to present product quality metrics, root cause analyses, and recommended actions to internal stakeholders and leadership. Strong ability to assess and review written product and project documentation for compliance. Preferred: Experience with verification and validation requirements, design of experiments, and requirements analysis for regulated products. Behaviors: Detail-oriented and committed to maintaining the highest standards of quality and regulatory compliance. Proactive and decisive, with the ability to independently prioritize tasks and resolve conflicts. Collaborative and team-oriented, with a focus on fostering productive working relationships across functions. Problem-solving mindset, focused on identifying root causes and driving effective solutions. Customer-focused, with a commitment to addressing product quality issues and ensuring customer satisfaction. Driven by continuous improvement, with a desire to optimize processes and enhance product quality. Experience: 5+ years of experience in engineering, preferably in a regulated industry such as medical devices. Hands-on experience with root cause analysis, product development, or R&D. Beneficial experience includes supporting complex medical devices (e.g., software, electromechanical systems) at the system level. Education: Bachelor's degree in Engineering (Mechanical, Electrical, Biomedical, or related field). Why join Hologic? We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. The annualized base salary range for this role is $97,600-$152,700 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand. Agency and Third-Party Recruiter Notice Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans. #LI-NT1

At Northwestern Medicine, every patient interaction makes a difference in cultivating a positive workplace. This patient-first approach is what sets us apart as a leader in the healthcare industry. As an integral part of our team, you'll have the opportunity to join our quest for better health care, no matter where you work within the Northwestern Medicine system. We pride ourselves on providing competitive benefits: from tuition reimbursement and loan forgiveness to 401(k) matching and lifecycle benefits, our goal is to take care of our employees. Ready to join our quest for better? Job Description The Program Manager, Quality reflects the mission, vision, and values of Northwestern Medicine, adheres to the organization's Code of Ethics and Corporate Compliance Program, and complies with all relevant policies, procedures, guidelines and all other regulatory and accreditation standards. The Program Manager, Quality is responsible for planning and coordinating all or a portion of the Quality program for Northwestern Memorial Hospital the direction of the Director of Quality. This role coordinates and leads the quality endeavor, coordinates with peers, and is responsible for implementation and follow up as outlined in the annual quality plan, ongoing priorities of leadership and quality committees, and compliance with relevant standards monitored by The Joint Commission (TJC) and other agencies. This position will advance the use of quality evaluation and improvement strategies to achieve key organizational goals in quality and patient safety. The Program Manager partners with administrative, physician, nursing, ancillary leadership and other system function teams to advance the quality agenda through the development and implementation of plans and strategies that facilitate the achievement of strategic organizational goals. Responsibilities: Provide leadership and operational implementation of assigned Clinical Quality activities Conduct detailed, sophisticated, accurate and creative analyses of data at NMHC and outside NMHC (e.g. benchmarks, comparative data) to identify quality opportunities. Advance performance compared to appropriate external benchmarks and optimize process and outcome metrics. Develop, conduct, implement and improve process improvement activities to improve high quality & high-reliability healthcare. Identify and utilize appropriate quality metrics to evaluate project or performance success based on stated purpose and needed outcomes. Implement effective quality planning Design quality plans, programs and policies, peer review, and best practices in partnership with senior medical and operational leaders. Lead the department to identify quality opportunities and concerns, in collaboration with the Director of Quality. Facilitate the implementation of systems and processes that promote a fair and just culture, and improve patient care. Support effective department operations and growth, and personal development Support, coach, teach, mentor, monitor and evaluate the work of others conducting quality work (as directed) and personally conduct, coordinate, facilitate, and participate in quality assessments, improvement efforts, committees, etc. Oversee effective use of budget and other resources as delegated. Will supervise projects with organizational impact, and intermittent staff assignments. Responsible for self-development and professional engagement, including knowledge of the literature and attendance at professional meetings, preparation of manuscripts, posters and presentations, involvement of with local and national task forces as relevant. Additional/Clarified Essential Functions: Under the leadership of the Quality Director: SME on external rankings methodology and overall impact to hospital ranking, specialties, and procedures and conditions. External Methodology Vizient expert including changes in annual release and advocate for changes when possible Analyze and interpret data, develop reports and dashboards, identify performance challenges and opportunities to improve care; monitor progress Create and lead action plans of multiple workstreams to improve patient outcomes and lead improvement projects in targeted areas. Advocate and collaborate with Vizient for improved and transparent methods. Identify emerging needs for NM strategic priorities, monitoring external measurement and performance and emerging literature. Exhibits confidence, credibility, and professionalism to influence decision-making for NMHC senior leadership Delivers clear, concise, and persuasive messages tailored to executive audiences, ensuring alignment and engagement across teams. Qualifications Required: Bachelor's degree in Nursing or Allied Health Profession or a Master's degree in a healthcare related field 5+ years of work experience, with 4+ years in a healthcare setting, and 3+ years of quality, patient safety, or relevant experience Highly effective and experienced at facilitation of teams including complex multi-disciplinary projects Expert knowledge of quality measures and measurement, mastery of performance improvement methodologies (i.e. DMAIC), analytic tools and methods, including implementation with measurable results Advanced competence with Excel and data analysis Excellent writing and presentation skill Preferred: Master's degree Certified Professional in Healthcare Quality (CPHQ) or Certified Professional in Patient Safety (CPPS) or other evidence of advanced commitment to profession. Familiarity with major sources of measures, literature, and quality- and patient-safety-related federal and state policy. Experience with clinical outcomes, safety, and patient satisfaction data Additional Information Northwestern Medicine is an equal opportunity employer (disability, VETS) and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, gender identity, veteran status, disability, sexual orientation or any other protected status. Background Check Northwestern Medicine conducts a background check that includes criminal history on newly hired team members and, at times, internal transfers. If you are offered a position with us, you will be required to complete an authorization and disclosure form that gives Northwestern Medicine permission to run the background check. Results are evaluated on a case-by-case basis, and we follow all local, state, and federal laws, including the Illinois Health Care Worker Background Check Act. Benefits We offer a wide range of benefits that provide employees with tools and resources to improve their physical, emotional, and financial well-being while providing protection for unexpected life events. Please visit our Benefits section to learn more. Sign-on Bonus Eligibility: Internal employees and rehires who left Northwestern Medicine within 1 year are not eligible for the sign on bonus. Exception: New graduate internal employees seeking their first licensed clinical position at NM may be eligible depending upon the job family.

At WHOOP, we're on a mission to unlock human performance and healthspan. WHOOP empowers users to perform at a higher level through a deeper understanding of their bodies and daily lives. As a Field Quality Engineer II, you will work closely with WHOOP Manufacturing, Supply Chain & Operations, Hardware Engineering, and Membership Services teams as you will be responsible for field quality, triage on high customer impact returns, and RMA processes/metrics. You will hands-on debug failures and product returns, analyze and action field diagnostic data, and conduct 8D based Root Cause Corrective Action (RCCA) to ensure clear and actionable learnings are fed back to technical teams to enable design improvement so our members have a best in class hardware product experience.RESPONSIBILITIES: Lead returned product engineering failure analysis, RMA diagnostic testing, and project management to achieve yield, product lifetime, and field performance improvements Perform 8D based RCCA for returns and field failures. Analyze results and present detailed, actionable reports to engineering teams and manufacturing partners Analyze returned product, field reliability and field performance data. Create data visualizations for stakeholder visibility Improve and monitor factory and supplier quality control processes and MRB disposition Understand, analyze, and optimize product return strategy, member communications, and field troubleshooting decision trees and SOPs Develop field reliability test plans and protocols, partnering with external engineering labs and manufacturing partners to leverage their testing and analysis capabilities Develop field validation plans for production changes including plan creation, risk level assessment, performance and failure analysis, and support change approval/rejection Project manage field quality initiatives with suppliers, external test providers, and engineering labs, owning the technical definition, schedule, cost, and coordination with all stakeholders and contributors QUALIFICATIONS: Degree in Mechanical or Electrical Engineering, a related field, or equivalent practical experience 3+ years experience in quality engineering focusing on field quality, reliability, aftermarket reverse logistics, and transforming data into technically meaningful metrics Understand fundamentals of electromechanical design, manufacturing, and engineering test Strong written and verbal communication skills of technical details and engineering analyses with domestic and international teams Impeccable attention to detail, time management, and organizational skills Self motivated and proactive, demonstrating creative and critical thinking capabilities in a team environment Six Sigma Green Belt certification is preferred. Ability to travel domestically and internationally (up to 25%) This role is based in the WHOOP office located in Boston, MA. The successful candidate must be prepared to relocate if necessary to work out of the Boston, MA office. Interested in the role, but don't meet every qualification? We encourage you to still apply! At WHOOP, we believe there is much more to a candidate than what is written on paper, and we value character as much as experience. As we continue to build a diverse and inclusive environment, we encourage anyone who is interested in this role to apply. WHOOP is an Equal Opportunity Employer and participates in E-verify to determine employment eligibility. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Who We Are Noah Medical is building the future of medical robotics. Our next generation robotic platform targets early diagnosis and treatment of patients across multiple indications. We are looking for exceptional engineers and key team members. Our incredibly talented team of engineers, innovators, and industry leaders bring years of experience from the top healthcare companies in the world, including: Intuitive, Auris, Stryker, Johnson & Johnson, Boston Scientific, Verb Surgical, Mako, Think Surgical, Medrobotics, and Hansen. We are looking for talented, motivated and ambitious team members to revolutionize robotic surgery. A Day In The Life Of Our Sr. Product Quality Engineer at Noah Medical Able to lead efforts into the investigation of returned field devices, including flexible endoscopes, disposable devices, and capital devices/equipment Take the lead on methodical root cause analysis projects. Document the findings in clearly written reports/presentations Review engineering drawings, understand their impact on parts received, and propose opportunities for design improvements Design of test methods and fixtures in order to facilitate efficient study of returned devices Mentor less experienced engineers in the process of effective root cause analysis. Collaborate with design, manufacturing, and quality teams to drive consistent, high-quality parts and assemblies About You B.S. or M.S. in mechanical engineering or related engineering discipline Min 7 years of experience in the medical device industry Demonstrated history of applying creative problem solving ability to difficult technical problems At least 5 years of leading root cause efforts of clinical context and use of medical devices Ability to manage and analyze large sets of data and effectively communicate results of data analysis. Proficient in use of CAD Experience assessing products produced by various fabrication methods used in single use, complex medical devices(e.g. machining, plastic injection molding, MIM, laser cutting, stamping, rapid prototyping). Demonstrated ability to work and mentor successfully in a team environment. Demonstrated strong project management skills. Eagerness to learn and to contribute to state of the art technology #LI-Hybrid Pay Transparency The Pay Range for this position is listed. Noah Medical offers a comprehensive benefits package including: competitive pay, health insurance, 401K and stock purchase plans, tuition reimbursement, paid time off plus holidays, and a flexible approach to work with remote, hybrid, field or office work schedules. Actual pay will be adjusted based on an individual's skills, experience, education, and other job-related factors such as location as permitted by law. Total compensation may also include additional forms of incentives. California Pay Range$120,600-$150,800 USD Benefits & Perks (For Full Time Employees): Competitive Salary Comprehensive health insurance including Medical, Dental and Vision + HSA and FSA options Equity & Bonus Program Life Insurance (company paid & supplemental) and Disability insurance Mental health support through medical insurance programs Legal and Pet Insurance 12+ paid holidays, 15-20 days of PTO + sick time Paid parental leave In-office snacks and beverages In-office lunch stipend Learning & Development Opportunities: On-demand online training and book reimbursement Team building and company organized social and celebration events Noah Medical may offer remote, hybrid, or onsite work arrangements within the state of California depending on the specific team and/or role where applicable. Noah Medical is an Equal Opportunity Employer. We celebrate diversity and are committed to ensuring an inclusive environment for our employees. Applicants are considered for all positions without regard to race, color, religion, sex or gender, gender identity or expression, sexual orientation, national origin, ancestry, age, genetic information, physical or mental disability, marital or protected military or veteran status, or any other consideration made unlawful by federal, state or local laws. Please visit our Careers Page to view our latest openings. NO AGENCIES PLEASE - Please do not outreach to any managers or submit any resumes without a signed agreement from Talent Acquisition. Resumes shared with anyone at Noah Medical without a signed agreement will be considered your gift to us and no fee will be paid.

The Product Quality Engineer I will be responsible for quality assurance activities including product quality engineering, non-conforming material report write ups and investigation, statistical process control, process improvements, and quality control oversight. Essential Duties and Responsibilities: Develop and maintain strong internal working relationships across restor3d. Understand the objectives, responsibilities, and mission of the Quality department and work towards those goals. Prioritize and plan work activities; adapt for changing conditions. Assist in maintaining the quality system in accordance with applicable regulatory requirements. Identify quality system process improvements and implement solutions. Assist with the Corrective/Preventive Action (CAPA) program. Assist with the Customer Complaint system by performing complaint investigations, including root cause analysis. Assist with product inspections as needed. Perform Internal Quality Audits of the quality system Participate in supplier selection and approval process, including supplier audits and review of quality data. Perform investigations of non-conformances and drive corrective actions. Participate on cross-functional product development teams. Participate in product/process validations. Perform risk assessments, gathering cross-functional team input. Establish and trend quality metrics and data. Participate in third party audits against ISO 13485 and FDA 21 CFR Part 820 requirements. Other responsibilities as assigned. Qualifications: Bachelor of Science in Engineering, Science, or Biomedical. 3 months to 2 years of Quality Assurance/Quality Engineering experience in an FDA regulated environment - preferably QSR (21 CFR Part 820) Skills, Abilities, Competencies Required: Excellent written and verbal communication skills. Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail. Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness. Strong organizational, analytical, and time-management skills. Able to self-motivate and work both independently and as part of a team. Must have a solid knowledge of Microsoft office. Must be able to work in a team environment, execute responsibilities with minimal direct supervision, and have a high attention to detail. restor3d is an Equal Opportunity Employer

The Product Quality Engineer II will be responsible for quality assurance activities including product quality engineering, non-conforming material report write ups and investigation, statistical process control, process improvements, and quality control oversight. Essential Duties and Responsibilities: Develop and maintain strong internal working relationships across restor3d. Understand the objectives, responsibilities, and mission of the Quality department and work towards those goals. Prioritize and plan work activities; adapt for changing conditions. Assist in maintaining the quality system in accordance with applicable regulatory requirements. Identify quality system process improvements and implement solutions. Lead or assist with the Corrective Action/Preventive Action (CAPA) program. Lead or assist with the Customer Complaint system by performing complaint investigations, including root cause analysis. Assist with product inspections as needed. Perform Internal Quality Audits of the quality system Participate in supplier selection and approval process, including leading supplier audits and review of quality data. Perform investigations of non-conformances and drive corrective actions. Participate on cross-functional product development teams. Participate in product/process validations. Perform risk assessments, gathering cross-functional team input. Employ statistical techniques and rationale in decision-making activities driven to support non-conformance trending, CAPA effectiveness, part qualification, and process monitoring. Establish and trend quality metrics and data. Participate in third party audits against ISO 13485 and FDA 21 CFR Part 820 requirements. Other responsibilities as assigned. Qualifications: Bachelor of Science in Engineering, Science, or Biomedical. 2+ years of Quality Assurance/Quality Engineering experience in the medical device industry and/or experience in an FDA regulated environment is required. Knowledge of FDA 21 CFR Part 820 and ISO 13485, preferred. ASQ certification (Certified Quality Engineer, Certified Quality Auditor, Certified Biomedical Auditor) a plus. Skills, Abilities, Competencies Required: Excellent written and verbal communication skills. Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail. Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness. Strong organizational, analytical, and time-management skills. Able to self-motivate and work both independently and as part of a team. Must have a solid knowledge of Microsoft office. Must be able to work in a team environment, execute responsibilities with minimal direct supervision, and have a high attention to detail. Demonstrated proficiency with FDA and ISO standards for Medical Devices. Restor3d is an Equal Opportunity Employer

The Product Quality Engineer I will be responsible for quality assurance activities including product quality engineering, non-conforming material report write ups and investigation, statistical process control, process improvements, and quality control oversight. Essential Duties and Responsibilities: • Develop and maintain strong internal working relationships across Conformis. • Understand the objectives, responsibilities, and mission of the Quality department and work towards those goals. • Prioritize and plan work activities; adapt for changing conditions. • Assist in maintaining the quality system in accordance with applicable regulatory requirements. • Identify quality system process improvements and implement solutions. • Assist with the Corrective/Preventive Action (CAPA) program. • Assist with the Customer Complaint system by performing complaint investigations, including root cause analysis. • Assist with product inspections as needed. • Perform Internal Quality Audits of the quality system • Participate in supplier selection and approval process, including supplier audits and review of quality data. • Perform investigations of non-conformances and drive corrective actions. • Participate on cross-functional product development teams. • Participate in product/process validations. • Perform risk assessments, gathering cross-functional team input. • Establish and trend quality metrics and data. • Participate in third party audits against ISO 13485 and FDA 21 CFR Part 820 requirements. • Other responsibilities as assigned. Qualifications: • Bachelor of Science in Engineering, Science, or Biomedical. • 3 months to 2 years of Quality Assurance/Quality Engineering experience in an FDA regulated environment - preferably QSR (21 CFR Part 820) Skills, Abilities, Competencies Required: • Excellent written and verbal communication skills. • Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail. • Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness. • Strong organizational, analytical, and time-management skills. • Able to self-motivate and work both independently and as part of a team. • Must have a solid knowledge of Microsoft office. • Must be able to work in a team environment, execute responsibilities with minimal direct supervision, and have a high attention to detail. restor3d/ Conformis is an Equal Opportunity Employer

The Product Quality Engineer II will be responsible for quality assurance activities including product quality engineering, non-conforming material report write ups and investigation, statistical process control, process improvements, and quality control oversight. Essential Duties and Responsibilities: • Develop and maintain strong internal working relationships across Conformis. • Understand the objectives, responsibilities, and mission of the Quality department and work towards those goals. • Prioritize and plan work activities; adapt for changing conditions. • Assist in maintaining the quality system in accordance with applicable regulatory requirements. • Identify quality system process improvements and implement solutions. • Lead or assist with the Corrective Action/Preventive Action (CAPA) program. • Lead or assist with the Customer Complaint system by performing complaint investigations, including root cause analysis. • Assist with product inspections as needed. • Perform Internal Quality Audits of the quality system • Participate in supplier selection and approval process, including leading supplier audits and review of quality data. • Perform investigations of non-conformances and drive corrective actions. • Participate on cross-functional product development teams. • Participate in product/process validations. • Perform risk assessments, gathering cross-functional team input. • Employ statistical techniques and rationale in decision-making activities driven to support non-conformance trending, CAPA effectiveness, part qualification, and process monitoring. • Establish and trend quality metrics and data. • Participate in third party audits against ISO 13485 and FDA 21 CFR Part 820 requirements. • Other responsibilities as assigned. Qualifications: • Bachelor of Science in Engineering, Science, or Biomedical. • 2+ years of Quality Assurance/Quality Engineering experience in the medical device industry and/or experience in an FDA regulated environment is required. • Knowledge of FDA 21 CFR Part 820 and ISO 13485, preferred. • ASQ certification (Certified Quality Engineer, Certified Quality Auditor, Certified Biomedical Auditor) a plus. Skills, Abilities, Competencies Required: • Excellent written and verbal communication skills. • Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail. • Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness. • Strong organizational, analytical, and time-management skills. • Able to self-motivate and work both independently and as part of a team. • Must have a solid knowledge of Microsoft office. • Must be able to work in a team environment, execute responsibilities with minimal direct supervision, and have a high attention to detail. • Demonstrated proficiency with FDA and ISO standards for Medical Devices. restor3d/ Conformis is an Equal Opportunity Employer

The Product Quality Engineer I will be responsible for quality assurance activities including product quality engineering, non-conforming material report write ups and investigation, statistical process control, process improvements, and quality control oversight. Essential Duties and Responsibilities: Develop and maintain strong internal working relationships across restor3d. Understand the objectives, responsibilities, and mission of the Quality department and work towards those goals. Prioritize and plan work activities; adapt for changing conditions. Assist in maintaining the quality system in accordance with applicable regulatory requirements. Identify quality system process improvements and implement solutions. Assist with the Corrective/Preventive Action (CAPA) program. Assist with the Customer Complaint system by performing complaint investigations, including root cause analysis. Assist with product inspections as needed. Perform Internal Quality Audits of the quality system Participate in supplier selection and approval process, including supplier audits and review of quality data. Perform investigations of non-conformances and drive corrective actions. Participate on cross-functional product development teams. Participate in product/process validations. Perform risk assessments, gathering cross-functional team input. Establish and trend quality metrics and data. Participate in third party audits against ISO 13485 and FDA 21 CFR Part 820 requirements. Other responsibilities as assigned. Qualifications: Bachelor of Science in Engineering, Science, or Biomedical. 3 months to 2 years of Quality Assurance/Quality Engineering experience in an FDA regulated environment - preferably QSR (21 CFR Part 820) Skills, Abilities, Competencies Required: Excellent written and verbal communication skills. Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail. Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness. Strong organizational, analytical, and time-management skills. Able to self-motivate and work both independently and as part of a team. Must have a solid knowledge of Microsoft office. Must be able to work in a team environment, execute responsibilities with minimal direct supervision, and have a high attention to detail. restor3d is an Equal Opportunity Employer

The Product Quality Engineer will be responsible for product quality engineering/ quality assurance activities. This includes interpretation and implementation of quality standards to routine manufacturing, continuous improvement, and product release activities. Essential Duties and Responsibilities: Develop and maintain strong internal working relationships across Conformis. Understand the objectives, responsibilities, and mission of the Quality department and work towards those goals. Prioritize and plan work activities; adapt for changing conditions. Perform quality testing of CER and Purified water system. Perform product release activities (on an as needed basis). Administers the bioburden/endotoxin testing program as required per procedure. Trend in-process manufacturing data and environmental monitoring data and produce summary reports. Implement and maintain quality system in accordance to applicable regulatory requirements. Initiate and participate in resolution of non-conforming materials. Review Non-Conformity Reports for sub-assemblies and finished goods. Administer the calibration system. Review of the daily activities for production start-up. Develop and upgrade procedures for continuous improvement as required by the quality system. Perform Internal Quality Audits of the quality system. Develop qualification/validation plans. Conduct product/process validations (sterilization). Develop and implement statistical sampling plans. Assist in the investigation of product complaints. Assist in corrective action investigations. Perform internal audits to drive continuous improvement (minimum of 2 per year). Other responsibilities as assigned. Qualifications: Bachelor of Science in Engineering or Science. 1-3 years of Quality Assurance/Quality Engineering and experience in a FDA regulated environment is preferred - with QSR (21 CFR Part 820) experience if possible (Job Specific Qualifications). Skills, Abilities, Competencies Required: Excellent written and verbal communication skills. Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail. Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness. Strong organizational, analytical, and time-management skills. Able to self-motivate and work both independently and as part of a team. Must have a solid knowledge of Microsoft office 2010. Knowledge of FDA and ISO standards for Medical Devices is a plus. Knowledge of Statgraphics or Minitab is a plus. Conformis is an Equal Opportunity Employer