Quality Engineer jobs at Getinge Usa, Inc.

Responsible for maintaining compliance with all State, Federal regulatory guidelines and third party payers; Accreditation standards and quality activities of the organization. Provides leadership and expertise to facilitate and support staff competency through best practice teaching, consultation, collaboration and the use of current knowledge, research and technology. Essential Functions: Ensures that there are processes in place to monitor and measure all activities related to quality assessment and performance improvement (QAPI). Provides direction and coordination of quality improvement activities utilizing continuous quality improvement principles and methodologies. Provides education and training to organization personnel on the QAPI plan, and team development. Performs clinical record review activities for data collection. Compiles, analyzes, trends and reports quality data in the following areas: hospice & palliative care quality reporting, patient care, safety, risk management, infection control, outcomes and customer satisfaction. Works collaboratively with nursing supervisors/managers/directors to assure documentation is complete and consistent with care and reflects legal requirements. Promotes professional standards of care, compliance with regulatory requirements, third-party payor reimbursement models, and organization policies and procedures through use of performance improvement methodology. Ensures complete responses to Additional Development Requests (ADRs), Comprehensive Error Rate Testing (CERT), Recovery Audit Contractor (RAC) etc., requests and participates in appeal processes. Participates in the development and annual revision of Quality Assessment and Improvement Plans and Program Evaluation. Participates in analyzing, developing, coordinating and implementing plans of correction for noted deficiencies. Makes recommendations to the education committee for mandatory education related to accreditations and compliance topics. Acts as a mentor and resource for staff with regard to performance improvement methodology, regulatory, educational and patient care issues. Participates in the evaluation, development and revision of policies and procedures for hospice. Participates on various committees related to Organizational Quality and Education. Maintains professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal and professional networks. Adheres to organizational Code of Conduct, policies, procedures, protocols and processes and all regulatory and legal requirements Adheres to the C.A.R.E. Model of Service: courtesy, acknowledgement, response and empathy. Qualifications: Registered Nurse with a baccalaureate degree in nursing, preferably a Master's Degree in a health-related discipline. Minimum three (3) years' direct hospice experience may be considered in lieu of BSN degree. Requires two to three years related quality and accreditation experience. Current RN licensure in State of Michigan and maintain such licensure in accordance with applicable laws and regulations and perform within the scope specified. Extensive knowledge of Hospice regulations and standards preferred. Excellent written, verbal and interpersonal skills necessary to interact with a wide variety of staff. Is self-directed and able to work with minimal supervision. Requires knowledge of quality assessment and utilization review functions, principles and practices. Theoretical and practical knowledge of principles of adult learning and ability to develop and present educational programs. Quantitative, analytical and computer skills to collect, analyze, display and present data. The physical and sensory demands of the position include: vision, effective speech and hearing for extensive telephone contact; repetitive motion; traveling; driving or riding in motor vehicle; standing, sitting, walking, bending, reaching, and stretching; lifting up to forty five (45) pounds unassisted and the ability to assist in lifting patients using appropriate lifting techniques and/or devices. Must be able to work variable hours/shifts and/or days, including weekends. Must have ability to occasionally work extended days. Must be eligible to work in the United States.

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.

Veridiam is a strategic manufacturing partner specializing in precision fabrication of components and assemblies made from exotic metals for critical applications in aerospace, defense, medical, nuclear, and space. Our roots were formed in the exacting nuclear and aerospace industries, expanded into medical where we have supplied critical components to a global customer base. Veridiam's ability to work with challenging materials such as titanium alloys, nickel-based superalloys, refractory metals, and specialty stainless steels ensures reliable, mission-ready products for our customers' most vital programs. As a trusted partner, Veridiam provides technical collaboration, quality assurance, and supply chain reliability essential to advancing innovation and operational success across these highly regulated industries and results for mission-critical parts made from titanium alloys, nickel-based superalloys, refractory metals and more. At Veridiam we recognize that talent is at the forefront of our organization and define who we are in today's industry. You will work in a highly regulated, precision manufacturing environment where safety, documentation integrity, dimensional control (“True Diameter”) and traceability are paramount. Veridiam is looking for a Materials Engineer for our El Cajon facility. Interested candidates should apply directly to our website at: Careers - Strategic Manufacturing Partner > Veridiam Position Summary Extract, research, develop, test, and improve materials used in our products and processes. Perform tests and conduct research on properties, performance and applications of metals including high-performance alloys. Analyze material behavior under various conditions and prepare technical reports. Essential Duties and Responsibilities Perform assigned routine and advanced or complex tests on raw material, product in process, re-worked material, finished goods and/or developmental samples in accordance with customer and/or quality standards/specifications. Conduct research on the properties, performance, and applications of metals including high-performance alloys such as stainless steel, titanium, and nickel alloys. Develop and test new materials to improve product durability, performance, and efficiency. Perform failure analysis and recommend design/material improvements. Analyze material behavior under various conditions (stress, temperature, corrosion, wear, etc.). Review and manage internal and external material lab test results. Develop and maintain processes for new product introduction. Prepare technical reports, specifications, and documentation for internal and customer use. Prepare, organize, and maintain necessary samples, forms, documentation and trend charts. May provide data and analysis to material review board to support resolution of issues, initial data support to supplier and/or customer notification. Ensure compliance with industry standards, safety regulations, and environmental requirements. Support process optimization and cost-reduction initiatives without compromising quality. Work collaboratively with cross-functional teams to ensure materials meet customer requirements and performance, quality and cost objectives. Provide and supply training for others in the area. Maintain clean and orderly work environment. Demonstrates ability to appear for work on time, follow directions from a supervisor, interact well with co-workers, understand and follow work rules and procedures, comply with company policies and procedures, goals and objectives, and accepts constructive feedback. Other duties as assigned, requested or needed. Position Requirements To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals to perform the essential functions. Education and Experience: Bachelor's degree in Materials Science, Materials Engineering, Metallurgy, Chemical Engineering or related field. Five (5) or more years' experience in manufacturing and/or familiarity of the international standards for testing metallic materials (ASTM E8) including steel products (ASTM A370) preferred or equivalent education and experience. Knowledge, Skills, and Abilities: Knowledge of metal forming, and/or machining methods preferred. Excellent written and verbal communication skills. Ability to read and interpret documents such as work orders, operating and maintenance instructions and procedure manuals and blueprints. Ability understand and follow standard operating and safety procedures. High-level attention to detail and commitment to quality standards. Strong problem-solving skills and technical expertise in materials science. The above statements are intended to describe, in broad terms, the general functions and responsibility levels assigned to this classification. Management has the right to change duties at any time to meet business needs. Pay Rate: The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience with the industry, education, geographic location, etc. Veridiam is an Equal Employment Opportunity/Affirmative Action Employer. Veridiam will recruit, hire, train and promote persons into all jobs without regard to age, race, color, religion, ancestry, medical condition, sex, sexual orientation, gender identity, national origin, status as a veteran or status as an individual with a disability or any other characteristic or classification protected by law. Access to our facility (and, therefore, employment) is restricted under the International Traffic in Arms Regulations (ITAR) and/or Export Administration Regulations (EAR) to U.S. Citizens, lawful permanent residents of the United States and properly licensed foreign persons. Applicants receiving a conditional offer of employment will be required to provide information to determine whether they are subject to these regulations and, if so, to assess their country of chargeability for export control purposes.

The achievers and courageous challenge-crushers we seek, have the following characteristics and skills: What You will Do: Quest Global is seeking a highly organized and detail-oriented Quality Engineer to join our team. In this role, you will ensure compliance with quality standards and continuous improvement within Gas Turbines Rotor Components Machining Department. This role involves monitoring manufacturing processes, conducting root cause analysis, and implementing corrective/preventive actions to maintain product integrity and customer satisfaction. The achievers and courageous challenge-crushers we seek, have the following characteristics and skills:• What You Will Do: Quality Assurance & Compliance Develop, implement, and maintain quality control procedures for rotor components machining processes. Ensure adherence to Siemens Energy quality standards and applicable industry standards. Inspection & Documentation Review engineering drawings, specifications, Prepare and maintain quality documentation, inspection reports, and RCAs, Corrective / preventive action records. Root Cause Analysis & Problem Solving Lead investigations using RCA, 8D, and CAPA methodologies for non-conformances. Drive corrective and preventive actions to eliminate recurring issues. Process Audits & Continuous Improvement Conduct internal/process audits of machining processes and identify improvement opportunities. Support Lean initiatives and process optimization projects. Collaboration & Communication Work closely with manufacturing engineers, machinists, and supervisors to resolve quality issues. Provide technical guidance and training on quality standards and best practices. What You Will Bring: Bachelor's degree in mechanical or manufacturing engineering. Minimum 7 years of experience in quality engineering within a machining or heavy manufacturing environment. Proficiency in quality tools: RCA, FMEA, PPAP and SPC Good understanding of CAD/CAM, CNC programming, and interpreting technical drawings with GD&T Strong knowledge of machining processes, CNC, CMM and precision components. Familiarity with SAP or similar ERP systems and Microsoft Office Suite. Certification in Six Sigma will be an added advantage Strong interpersonal skills Analytical and problem-solving skills with attention to detail. Ability to interpret complex engineering drawings and specifications. Strong communication and interpersonal skills for cross-functional collaboration. Knowledge of industry standards and regulatory requirements for turbine components. Ability to apply continuous improvement methods to increase manufacturing quality, efficiency, reliability, and cost effectiveness. Experience with advanced manufacturing processes Candidate should be familiar with Lean and or Six Sigma philosophies and their application in process capability and improvement Pay Range: (75K to 80K ). Compensation decisions are made based on factors including experience, skills, education, and other job-related factors, in accordance with our internal pay structure. We also offer a comprehensive benefits package, including health insurance, paid time off, and retirement plan. Work Requirements: This role is considered an on-site position located in Charlotte, NC. You must be able to commute to and from the location with your own transportation arrangements to meet the required working hours. Shop floor environment, which may include but not limited to extensive walking, and ability to lift up to 40 lbs.

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.

Hello Heart is on a mission to change the way people care for their hearts. The company provides the first app and connected heart monitor to help people track and manage their heart health. With Hello Heart, users take steps to control their risk of heart attacks and stroke - the leading cause of death in the United States. Peer-reviewed studies have shown that high-risk users of Hello Heart have seen meaningful drops in blood pressure, cholesterol and even weight. Recognized as the digital leader in preventive heart health, Hello Heart is trusted by more than 130 leading Fortune 500 and government employers, national health plans, and labor organizations. Founded in 2013, Hello Heart has raised more than $138 million from top venture firms and is a best-in-class solution on the American Heart Association's Innovators' Network and CVS Health Point Solutions Management platform. Visit ****************** for more information. About the Role: As Manager, Quality and Manufacturing, you will own both quality engineering and manufacturing engineering functions for our hardware products. You will ensure production readiness, product quality, process capability, and smooth issue resolution from prototype through mass production. Reporting into our Senior Director, Product and Manufacturing Operations, you will collaborate closely with suppliers, engineering, program management, and operations teams. You will create the structure, tools, and processes that enable consistent, high-quality manufacturing outcomes. Responsibilities Validate manufacturing readiness for NPI builds, including tools, fixtures, process flow, and documentation Partner with engineering teams on DFM and DFA reviews, qualification testing, and readiness milestones Create and maintain quality control plans across IQC, IPQC, and OQC processes Define and implement manufacturing process controls, test requirements, and build validation plan Lead structured root cause analysis using 8D, 5 Why, and Fishbone methodologies Drive corrective and preventive actions and verify long-term effectiveness Conduct line audits, capability studies (Cp and Cpk), and SPC monitoring to assess process health Monitor yields, reduce defects, and drive continuous improvement across production lines Assess supplier capability and lead onsite production reviews and factory evaluations Define incoming inspection criteria, sampling plans, and supplier quality alignment Maintain detailed build documentation, quality dashboards, and audit reports Qualifications 7+ years of experience in quality engineering, manufacturing engineering, or a related hardware-focused discipline Hands-on experience with production lines, fixtures, test equipment, and hardware manufacturing processes Strong understanding of quality systems including ISO 9001, ISO 13485, PFMEA, SPC, and Six Sigma Proven experience leading root cause analysis and driving corrective actions Experience working with contract manufacturers and suppliers, preferably in Asia Strong analytical skills with the ability to interpret yield trends, SPC data, capability studies, and defect data Excellent communication skills with the ability to present findings and recommendations Experience supporting NPI builds and high-volume product ramp is preferred Familiarity with reliability testing and environmental qualification is preferred Knowledge of hardware system integration spanning mechanical and electrical components is preferred Experience with DOE, process optimization, or Lean Manufacturing is preferred Mandarin language proficiency is a plus The US base salary range for this full-time position is $140,000.00 to $160,000.00. Salary ranges are determined by role and level. Compensation is determined by additional factors, including job-related skills, experience, and relevant education or training. Please note that the compensation details listed in US role postings reflect the salary only, and do not include equity or benefits. Hello Heart has a positive, diverse, and supportive culture - we look for people who are collaborative, creative, and courageous. Oh, and if you want to see some recent evidence of the fun things we do at Hello Heart, check out our Instagram page.

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.

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.

Hello Heart is on a mission to change the way people care for their hearts. The company provides the first app and connected heart monitor to help people track and manage their heart health. With Hello Heart, users take steps to control their risk of heart attacks and stroke - the leading cause of death in the United States. Peer-reviewed studies have shown that high-risk users of Hello Heart have seen meaningful drops in blood pressure, cholesterol and even weight. Recognized as the digital leader in preventive heart health, Hello Heart is trusted by more than 130 leading Fortune 500 and government employers, national health plans, and labor organizations. Founded in 2013, Hello Heart has raised more than $138 million from top venture firms and is a best-in-class solution on the American Heart Association's Innovators' Network and CVS Health Point Solutions Management platform. Visit ****************** for more information. About the Role: As Manager, Quality and Manufacturing, you will own both quality engineering and manufacturing engineering functions for our hardware products. You will ensure production readiness, product quality, process capability, and smooth issue resolution from prototype through mass production. Reporting into our Senior Director, Product and Manufacturing Operations, you will collaborate closely with suppliers, engineering, program management, and operations teams. You will create the structure, tools, and processes that enable consistent, high-quality manufacturing outcomes. Responsibilities Validate manufacturing readiness for NPI builds, including tools, fixtures, process flow, and documentation Partner with engineering teams on DFM and DFA reviews, qualification testing, and readiness milestones Create and maintain quality control plans across IQC, IPQC, and OQC processes Define and implement manufacturing process controls, test requirements, and build validation plan Lead structured root cause analysis using 8D, 5 Why, and Fishbone methodologies Drive corrective and preventive actions and verify long-term effectiveness Conduct line audits, capability studies (Cp and Cpk), and SPC monitoring to assess process health Monitor yields, reduce defects, and drive continuous improvement across production lines Assess supplier capability and lead onsite production reviews and factory evaluations Define incoming inspection criteria, sampling plans, and supplier quality alignment Maintain detailed build documentation, quality dashboards, and audit reports Qualifications 7+ years of experience in quality engineering, manufacturing engineering, or a related hardware-focused discipline Hands-on experience with production lines, fixtures, test equipment, and hardware manufacturing processes Strong understanding of quality systems including ISO 9001, ISO 13485, PFMEA, SPC, and Six Sigma Proven experience leading root cause analysis and driving corrective actions Experience working with contract manufacturers and suppliers, preferably in Asia Strong analytical skills with the ability to interpret yield trends, SPC data, capability studies, and defect data Excellent communication skills with the ability to present findings and recommendations Experience supporting NPI builds and high-volume product ramp is preferred Familiarity with reliability testing and environmental qualification is preferred Knowledge of hardware system integration spanning mechanical and electrical components is preferred Experience with DOE, process optimization, or Lean Manufacturing is preferred Mandarin language proficiency is a plus The US base salary range for this full-time position is $140,000.00 to $160,000.00. Salary ranges are determined by role and level. Compensation is determined by additional factors, including job-related skills, experience, and relevant education or training. Please note that the compensation details listed in US role postings reflect the salary only, and do not include equity or benefits. Hello Heart has a positive, diverse, and supportive culture - we look for people who are collaborative, creative, and courageous. Oh, and if you want to see some recent evidence of the fun things we do at Hello Heart, check out our Instagram page.

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

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

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 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

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 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 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

About Us Founded in 1908, Merz is a successful, family-owned specialty healthcare company with a rich history. As a leading global aesthetics business, our award-winning portfolio of injectables, devices, and skincare products empowers healthcare professionals to enhance confidence through aesthetic medicine. Our purpose is to fuel confidence by helping people look better, feel better, and live better. We believe you do not have to choose between living life and making a living. Live your best life with Merz Aesthetics. A Brief Overview Contributes to equipment projects and manufacturing process improvements. Provides insight and contributes to production reliability. Participates as a team member for technical operations sections of product development projects, including scale-up and production line design. Leads process development and equipment projects while maintaining schedules and meeting budgets. Success is measured through implementation of projects that meet desired outcome, budget, timeline, and manufacturing goals. What You Will Do Process design Coordinates implementation of manufacturing equipment, process automation, process expansions, and new initiatives. Includes project budgeting, design & interfacing with vendors of equipment and tooling, and maintaining appropriate documentation for new equipment and processes including qualification, verification, and validation. Process sustenance Identify production interruptions and establish risk mitigations. Troubleshoot equipment and processing issues in support of production goals. Determine calibration and maintenance needs of new equipment. Process evaluation Establish new product costs, develop and implement necessary SOP's, and establish processing, packaging and test specifications for products and equipment. Identify process inefficiencies and implement strategies, including automation and scale-up, to identified areas. Maintain Budgets Create and maintain project time lines and plans, accelerating where possible. Create project and/or capital budgets in cooperation with management to meet department budgets. Minimum Requirements Bachelor of Science (B.S.) in Biomedical Engineering, Mechanical Engineering, Chemical Engineering, or Physical Science. 1 year of relevant work experience. Preferred Qualifications Master of Science (M.S. or M.Sc.) in Engineering, Business, or related discipline. 3+ years of medical device or pharmaceutical process experience or similar experience in a regulated industry. Technical & Functional Skills Familiar with ISO 13485 / FDA QSR / GMP / Other medical industry regulations. Ability to formulate program strategy, budgets and timelines. Solidworks and/or AutoCAD. Six Sigma Methodologies. Statistical Analysis. Strong technical and problem-solving skills. Ability to communicate and write effectively. Benefits: Comprehensive Medical, Dental, and Vision plans 20 days of Paid Time Off 15 paid holidays Paid Sick Leave Paid Parental Leave 401(k) Employee bonuses And more! Your benefits and PTO start the date you're hired with no waiting period! Come join a company that is committed to being a trusted partner focused on our customers while not forgetting about our employees! This position is not eligible for employer-sponsored work authorization. Applicants must be legally authorized to work in the United States without the need for current or future employer-sponsored work authorization.