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  • Quality Systems Specialist

    Advantage Technical

    Quality engineer job in Waltham, MA

    Pay Rate: $40-$50/hr Work Model: Hybrid (Onsite Tuesday, Wednesday, Thursday) The Quality Systems Specialist, under the direction of the QS&C management team, supports global Quality Systems to ensure compliance, operational effectiveness, and fitness for intended use in alignment with applicable global SOPs. Key Areas of Accountability Quality System Governance & Support Assist in governance of Quality System applications, including harmonizing processes across sites Participate in meetings/workshops with Site Process Owners and business SMEs to gather requirements for system improvements and ongoing maintenance Join user forums to collect ongoing requirements, prioritize needs, and triage issues Follow up on requests, issues, and project activities; provide status updates to managers and working teams Change Control & Compliance Initiate and manage change controls through completion, including all required documentation Ensure systems remain in a validated state by supporting periodic user access reviews, change management, business administration, and deviations/CAPAs Support investigation, escalation, and resolution of system-related issues Validation & Documentation Support validation activities, including: Requirements gathering Validation planning Design qualification Authoring and executing test plans and test scripts Discrepancy management Preparing system descriptions and validation summary reports Maintain user-related documentation and ensure updates as new functionalities are introduced Cross-Functional & User Support Assist manager with communication between vendor/IT teams Provide customer support through system administration, training management, and onboarding of new users Generate metrics to support Quality Systems performance Support regular system updates/releases and provide assessments and recommendations on new features Academic & Technical Qualifications Bachelor's degree or higher in a relevant computer, technical, quality, or scientific discipline (multi‑disciplinary background preferred) 3-6 years of experience in a high‑volume commercial or clinical pharma/healthcare environment Proficiency in MS Word, Excel, and Quality System processes Experience with Veeva Vault Quality Docs, TrackWise, and ComplianceWire is a plus Strong understanding of US FDA and European regulatory requirements, GAMP, and phase‑appropriate compliance expectations Knowledge of Regulatory Compliance and ICH Guidelines General Comments Position Title: Quality Systems Specialist Pay Rate Range: $40-$50/hr
    $40-50 hourly 1d ago
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  • Quality Engineer I/II

    Vaxess Technologies

    Quality engineer job in Woburn, MA

    Vaxess is developing a pipeline of next-generation therapeutics on our novel micro-array patch platform. With only five minutes of wear-time on the skin, the Vaxess' patch combines room temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world. The Role: The Quality Engineer I / II will support Quality Assurance activities for Vaxess' combination product programs, with a strong focus on medical device design controls, risk management, and cGMP compliance. This role provides hands-on quality support across design and development, supplier oversight, process validation readiness, and batch record/data review, aligned with ISO 13485, 21 CFR 820, and applicable combination product regulations (21 CFR 4). Reporting to the Quality Assurance Manager, this role works cross-functionally with Manufacturing, Process Development, Quality Control, and Material Management to support compliant execution and ensure product quality and safety during early clinical development. Responsibilities: Support quality oversight of Vaxess combination product(s) to ensure compliance with safety, efficacy, and regulatory requirements. Administer and support the Quality Management System (QMS) in accordance with ISO 13485, 21 CFR 820, 21 CFR Part 4 (Combination Products), and applicable FDA and international regulations. Provide quality support for Design Control activities, including Design History File (DHF) maintenance, design reviews, Design Verification and Validation (DVV), and design changes. Support risk management activities, including development and maintenance of risk analyses (e.g., FMEA, hazard analyses) and linkage to design and process controls. Support process validation and qualification activities, including test method validation (TMV), process validation (PV), and equipment qualification, as applicable to Phase I and GMP-ready manufacturing. Participate in Material Review Board (MRB) activities, including nonconformance assessment, disposition, and documentation. Perform quality review and approval of batch records, executed manufacturing records, analytical data collection forms, test records, and technical or experimental reports. Collaborate in supplier quality management activities, including supplier qualification, auditing, monitoring, change evaluation, and periodic requalification. Author, review, and revise quality documentation, including SOPs, work instructions, test methods, protocols, reports, forms, and specifications. Support preparation, review, and organization of quality data and documentation for regulatory submissions and inspections. Contribute to continuous improvement initiatives within the QMS, including CAPA, deviation investigations, and quality metrics. Qualifications: Quality Engineer I: Minimum of 3 years of experience in Quality Assurance or Quality Engineering within a cGMP-regulated medical device or combination product environment. Quality Engineer II: Typically 4-5 years of progressive quality experience in medical devices, pharmaceuticals, biologics, or combination products. Working knowledge of ISO 13485 and FDA medical device Quality System Regulations (21 CFR 820); familiarity with combination product requirements strongly preferred. Experience supporting early-phase (preclinical to Phase I) product development is highly desirable. Experience with design controls, risk management (FMEA), and validation activities preferred. Experience reviewing GMP documentation such as batch records, test methods, protocols, and reports. Strong written and verbal communication skills, with the ability to clearly document technical and quality concepts. Proficiency with Microsoft Office applications (Word, Excel, PowerPoint). At Vaxess, we're bringing together exceptional talent to drive our product development forward. We value collaboration, curiosity, and a dynamic work environment. To apply, please submit your CV/resume to ****************** .
    $80k-104k yearly est. 2d ago
  • Aerospace & Defense Quality Engineer

    Biotalent

    Quality engineer job in Newburyport, MA

    Aerospace & Defense Quality Engineer - 6-Month Contract The Quality Engineer will be responsible for the development, implementation, maintenance, and continuous improvement of quality assurance processes in a regulated aerospace and defense environment. This role requires a strong data-driven mindset and hands-on quality engineering expertise to ensure compliance with AS9100/ISO standards, customer requirements, and regulatory obligations. Responsibilities Identify, analyze, and resolve quality issues using structured problem-solving methodologies Perform loss reporting and drive continuous improvement initiatives Design and implement process control, process improvement, testing, and inspection methods Develop, execute, and analyze quality metrics and reporting to support data-driven decision-making Perform and review First Article Inspections (FAI) in accordance with AS9102 requirements Interpret and apply GD&T per ASME Y14.5 to support inspection planning, nonconformance resolution, and root cause analysis Ensure compliance with AS9100 and applicable ISO standards across manufacturing and inspection processes Support and participate in internal, customer, and third-party quality audits Collaborate cross-functionally with engineering, manufacturing, and supply chain teams to ensure quality requirements are met throughout the product lifecycle Qualifications Bachelor's degree in Mechanical, Electrical, Manufacturing Engineering, or a related field (or equivalent experience) 4+ years of quality engineering experience in aerospace, defense, or another regulated manufacturing environment Strong working knowledge of AS9100, ISO 9001, and aerospace quality system requirements Experience performing and reviewing First Article Inspections (AS9102) Proficiency in interpreting engineering drawings and GD&T per ASME Y14.5 Strong knowledge of industry quality tools (e.g., SPC, FMEA, root cause analysis, CAPA) Demonstrated analytical, data-driven approach to problem solving Strong communication, documentation, and audit-support skills To learn more or apply, please contact me at ****************************. BioTalent Ltd is acting as an employment agency in relation to this opportunity.
    $79k-104k yearly est. 3d ago
  • Senior Industrial Process Engineer

    Radius Recycling

    Quality engineer job in Everett, MA

    & Responsibilities The Senior Process Engineer Technical Services is responsible for driving overall process technology implementation initiatives, continuous improvement / optimization programs, and leading innovation as it relates to Radius shredders, joint products, and other ferrous and non-ferrous operations. Improving yields, product quality and developing new product streams is a key pillar of the technical services department strategy and as such, this role is a key role in ensuring Radius' success in delivering on improved production metrics, throughput, product quality, sustainable low carbon products and reducing environmental footprint. Essential Functions Play a key role in implementing the metal recovery technology strategy and other technological improvements across the Radius enterprise. Project manage the overall execution of technology, continuous improvement and capital projects, ensuring proper resources are identified and assigned, projects are scoped and scheduled, and progress is monitored and managed. Lead process improvement and technological advancements in recycling with the goals of enhancing product quality, increasing metal recovery (reduce/divert landfill), help in creating new product streams (plastics, tires, and other adjacencies), and growing process efficiencies (throughput, mechanical availability, etc.). Establish and maintain necessary relationships and contracts with third party service providers, engineering firms, contractors, and consultants to ensure initiatives are appropriately engineered and adequately resourced. Act as a technical resource to the management teams (shredder, JP, maintenance, etc.) to assist with any technical opportunities that arise during operations. Leverage existing systems as well as define and establish new improved systems and processes. Ensure project budgets are effectively and efficiently utilized and met. Develop and deliver training and support tools for operations to institutionalize new technologies and process improvements. Assist in the development of fiscal year capital plans for any of the continuous improvement or reliability projects, including but not limited to, major maintenance projects, outages and others. Provides process training to employees as necessary. Work closely with Environmental, Health & Safety teams to ensure adherence to all Radius policies and procedures as well as identify opportunities for sustainability improvements and reducing impact on the environment. Ensuring a safe work environment for all employees, customers and visitors. Internal Control Responsibilities Supports Internal Control process which includes understanding, communicating, and complying with defined internal controls as well as suggesting and making modifications to the policies, procedures, and controls to better match the business. Communicates upward problems in operations, noncompliance with the code of conduct, or other policy violations or illegal actions. Interpersonal Contacts The Senior Process Engineer - Technical Services will be required to develop and maintain effective working relationships with Technical Services peers, the Operations team including Operations Managers (Shredder, Shear, Balers and Joint Products), Regional Managers, Purchasing Managers, Maintenance Managers at Radius facilities. The role will also be required to develop and maintain effective relationships with preferred service providers, equipment suppliers and contractors. Job Conditions This position will require frequent travel, up to 60% of the time. Visits to yards in each region can be expected to be under all weather conditions. Physical hazards may be present due to the equipment and machinery used throughout the recycling facility and the presence of the scrap itself. This position may require work beyond normally scheduled hours at times to support operations. Qualifications Bachelor's degree in an Engineering Field and 5 years of process engineering and project management experience; or equivalent combination of education, job experience and knowledge. Previous experience in the scrap metals recycling industry or an adjacent heavy industry (e.g., mining, gas & oil, municipal waste recycling, heavy fabrication & processing) is desirable. Experience leading and implementing continuous improvement / optimization projects. In addition, a keen drive for safety at work and understanding of environmental permitting processes. This position requires possession of a valid driver's license and the ability to drive an automobile. Ideal Competencies Ability to apply logical principles to solve practical problems and deal with many variables and determine a specific course of action. Ability to analyze data, to develop effective strategies from such analysis, and to translate these strategies into effective actions at the operational level. Accountability Integrity Customer Focus Use of functional expertise Teamwork Physical Requirements And Work Environment Able to: travel domestically and internationally, sit, stand, or walk for up to 6-8 hours per day; bend, crouch; climb, balance, push/pull, lift or carry up to 50 pounds. Able to write by hand and keyboard for extended periods of time. Communication is primarily by phone, email and in person, with other departments within the Radius Group. Visual acuity is needed for close detail work, preparing and analyzing data figures, accounting, and computer use.
    $70k-96k yearly est. 3d ago
  • Electronics Process Engineer, SMT & Rework

    Circuit Technology Center, Inc.

    Quality engineer job in Haverhill, MA

    Circuit Technology Center is a national leader in high reliability circuit board rework, repair, and modification. We support aerospace, defense, medical, and advanced technology customers who rely on us to solve complex board level challenges that require deep technical judgment and hands on expertise. We are hiring an Electronics Process Engineer, SMT & Rework to support our production and engineering teams. This role is ideal for an engineer with hands on electronics manufacturing or SMT experience who wants to deepen their expertise in board level rework, thermal processes, and high reliability electronics. This is a hands on, shop floor focused role working closely with experienced technicians on complex assemblies. What You'll Do Support SMT and rework process setups including thermal profiling, airflow control, and heat management Assist with hot air and rework system setup for complex assemblies Evaluate circuit boards for repairability, component sensitivity, and rework risk under guidance Support troubleshooting of SMT and rework related defects and failures Help interpret schematics, BOMs, drawings, and technical documentation Assist with process documentation, work instructions, and continuous improvement efforts Work directly with technicians to support safe, repeatable, and reliable rework processes What You Bring 2 to 8 years of experience in electronics manufacturing, SMT, process engineering, or related fields Hands on exposure to SMT assembly, reflow, or board level processes Basic understanding of thermodynamics, heat transfer, and component sensitivity Ability to read and interpret schematics and technical documentation Comfort working on the shop floor and supporting technicians Strong curiosity, problem solving mindset, and willingness to learn from senior engineers Preferred Experience Experience in aerospace, defense, medical, or other high reliability electronics environments Exposure to hot air rework systems, reflow ovens, x ray inspection, or failure analysis Familiarity with IPC standards such as IPC A 610, J STD 001, or IPC 7711 7721 This role offers hands on exposure to complex electronics, close mentorship from senior engineers, and the opportunity to grow into deeper technical ownership over time.
    $73k-111k yearly est. 4d ago
  • Cleaning Validation Engineer

    Veranova

    Quality engineer job in Devens, MA

    Who We Are: At Veranova, we believe people are our most important asset, and we are dedicated to building the most talented and diverse workforce in our industry. Our commitment to uncompromising focus on quality, compliance, safety, and excellence in delivery shapes everything we do. We are not just looking for skills; we are seeking innovative individuals who have a mindset open to learning and growth, and a desire to make a difference. Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility, we develop solutions and processes that support and accelerate innovation. Join us on our mission to enable current and next-generation therapeutics to improve and save the lives of patients. Role Overview: This role serves as the site SME for all cleaning validation and verification activities related to intermediate and API manufacturing, including facility surfaces and equipment. You'll work closely with cross-functional teams to ensure regulatory compliance and implement effective cleaning strategies that meet customer expectations. This position is key to maintaining high quality and safety standards across manufacturing operations. Additionally, you'll manage the environmental and purified water monitoring programs to ensure consistent product quality throughout the process. Core Responsibilities: Lead the development, execution, and validation of cleaning procedures for equipment, production lines, and facilities. Write and review cleaning validation protocols and reports in compliance with regulatory requirements, ensuring that all materials are free of any residues or contaminants. Coordinate and conduct sampling (e.g., swab, rinse, and surface) and analytical testing to validate cleaning processes and confirm cleaning effectiveness. Develop and maintain cleaning validation schedules to ensure timely completion of required validations Review cleaning validation data, ensuring it meets established acceptance criteria, and make recommendations for process improvements. Qualifications: Required Minimum 7 years of quality assurance experience with an undergraduate degree in engineering, science or related field Minimum of 3 years of experience in contamination control, cleaning validation, environmental monitoring, and/or purified water systems, preferably in a pharmaceutical or biotech manufacturing environment (API CDMO experience is highly desirable) Proven leadership experience in pharmaceutical, API/intermediate, medical device, biologics or related FDA industry Strong knowledge of cGMP, FDA, EMA, ICH guidelines, and other regulatory standards related to contamination control, cleaning validation, environmental monitoring, and purified water systems Experience with microbiological sampling, environmental monitoring, and testing of purified water systems in a regulated pharmaceutical environment Proficiency with risk assessment tools such as FMEA Previous experience working in cross-functional and project-based environments Experience creating metrics for driving continuous improvement Excellent analytical, written and verbal communication and presentation skills and a mindset that promotes a positive work culture Hands-on experience with cleaning validation, TOC analysis, and bioburden reduction strategies Driven and detail-oriented, with a strong understanding of cGMP regulations and previous experience in cleaning validation Experience driving complex projects with the ability to initiate, prioritize, and successfully complete tasks Proven experience working effectively in team situations and as an individual contributor Demonstrated behaviours that model the Veranova culture to achieve an inclusive environment and exceptional business results The ideal candidate will have hands-on experience with sterile and cleaning validation processes, strong technical writing skills, and the ability to execute validation protocols independently Experience in a fast-paced work environment Preferred Certification in contamination control (e.g., PDA Certification in Contamination Control). Knowledge of risk-based approaches to cleaning validation (e.g., Risk Assessment and ICH Q9) Experience with continuous improvement methodologies such as Lean or Six Sigma desire Familiarity with environmental monitoring equipment and purified water system design and validation Salary Range : $90,000 - $100,000 annual base salary Our Commitment: Health & Wellness: Comprehensive health & wellness benefits. Access to mental health resources and wellness programs. Generous PTO and holiday pay policies. Financial Wellness: Veranova is committed to fair and transparent compensation practices. This includes a competitive base salary, eligibility for performance-based bonuses, and an attractive 401(k) Plan with company match. Salary ranges reflect the scope and expectations of the role, and are based on market data, internal equity, and role-specific factors. Final compensation may vary depending on experience, skills, education, and business needs. Professional Development: Opportunities for continuous learning through LinkedIn Learning, workshops, conferences, and mentorship. Tuition Assistance for Undergraduate and Graduate degree programs. Inclusive Culture: At Veranova, an inclusive culture is integral to our values. We welcome people with diverse experiences and perspectives who share our mission to improve and save lives. Even if you don't meet every qualification, we encourage you to apply. Veterans, first responders, and those transitioning from military to civilian life bring valuable skills that strengthen our team. Additional Information: Applicants for this role must be authorized to work in the United States without further employer sponsorship. Agency and Search Firm Representatives: Veranova does not accept unsolicited resumes from agencies and/or search firms for this job posting. All your information will be kept confidential according to EEO guidelines. Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity and/or expression, physical or mental disability, genetic information, citizenship, marital status, veteran status, or any other characteristic protected by federal, state, or local law. All applications are carefully considered, and your details will be stored on our secure Application Management System. This is used throughout Veranova for the selection of suitable candidates for our vacancies as they arise. Veranova respects your privacy and is committed to protecting your personal information. For more information about how your personal data is used please view our privacy notice .
    $90k-100k yearly 3d ago
  • Quality/Regulatory Manager

    Analog Devices, Inc. 4.6company rating

    Quality engineer job in Wilmington, MA

    About Analog Devices Analog Devices, Inc. (NASDAQ: ADI ) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, and software technologies into solutions that help drive advancements in digitized factories, mobility, and digital healthcare, combat climate change, and reliably connect humans and the world. With revenue of more than $9 billion in FY24 and approximately 24,000 people globally, ADI ensures today's innovators stay Ahead of What's Possible. Learn more at ************** and on LinkedIn and Twitter (X). Job Description: Quality and Regulatory Manager Job Title: RA/QA Manager Location: US-based , Wilmington, MA (remote will be considered) Function: Regulatory and Quality Reports to: Business Lead Analog Devices, Inc. (NASDAQ: ADI ) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, and software technologies into solutions that help drive advancements in digitized factories, mobility, and digital healthcare, combat climate change, and reliably connect humans and the world. With revenue of more than $9 billion in FY24 and approximately 24,000 people globally, ADI ensures today's innovators stay Ahead of What's Possible. Learn more at ************** and on LinkedIn and Twitter (X). You will be working within a small, stealth group of talented individuals at ADI focused on next-generation technologies solving some of the world's toughest problems around human and planetary health. We are seeking an experienced and highly motivated Quality and Regulatory Manager to lead the development, implementation, and maintenance of our Quality Management System (QMS) and oversee regulatory submissions for medical devices and life science products. The ideal candidate will have proven expertise in U.S. FDA regulatory submissions, including successful 510(k) approvals, and will ensure compliance with applicable domestic and international regulations. Key Responsibilities * Develop, implement, and maintain a comprehensive Quality Management System (QMS) aligned with ISO 13485, FDA QSR, and other applicable regulations. * Lead the preparation, submission, and maintenance of regulatory submissions including FDA 510(k), CE Mark Technical Files, and international registrations. * Ensure company-wide compliance with all relevant quality and regulatory standards. * Manage internal and external audits, inspections, and corrective/preventive actions (CAPA). * Provide regulatory strategy and guidance to cross-functional teams during product development and commercialization. * Establish and maintain policies, procedures, and training programs to support quality and regulatory compliance. * Monitor changes in global regulatory requirements and advise management on their potential impact. * Serve as the primary liaison with regulatory agencies and notified bodies. * Lead risk management activities and ensure compliance with ISO 14971 requirements. * Support post-market surveillance activities, including complaint handling and adverse event reporting. Qualifications and Experience * Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, or related field (Master's preferred). * Minimum of 10 years of progressive experience in quality and regulatory roles within the medical device or life sciences industry. * Proven track record of successful FDA 510(k) submissions and approvals. * Strong knowledge of ISO 13485, FDA QSR, ISO 14971, MDR, and other relevant regulatory frameworks. * Experience managing QMS development, implementation, and continuous improvement. * Demonstrated ability to interface effectively with regulatory bodies, auditors, and internal teams. * Excellent organizational, leadership, and communication skills. * Ability to work independently and collaboratively in a fast-paced environment. For positions requiring access to technical data, Analog Devices, Inc. may have to obtain export licensing approval from the U.S. Department of Commerce - Bureau of Industry and Security and/or the U.S. Department of State - Directorate of Defense Trade Controls. As such, applicants for this position - except US Citizens, US Permanent Residents, and protected individuals as defined by 8 U.S.C. 1324b(a)(3) - may have to go through an export licensing review process. Analog Devices is an equal opportunity employer. We foster a culture where everyone has an opportunity to succeed regardless of their race, color, religion, age, ancestry, national origin, social or ethnic origin, sex, sexual orientation, gender, gender identity, gender expression, marital status, pregnancy, parental status, disability, medical condition, genetic information, military or veteran status, union membership, and political affiliation, or any other legally protected group. EEO is the Law: Notice of Applicant Rights Under the Law. Job Req Type: Experienced Required Travel: Yes, 10% of the time Shift Type: 1st Shift/Days The expected wage range for a new hire into this position is $106,500 to $159,750. * Actual wage offered may vary depending on work location, experience, education, training, external market data, internal pay equity, or other bona fide factors. * This position qualifies for a discretionary performance-based bonus which is based on personal and company factors. * This position includes medical, vision and dental coverage, 401k, paid vacation, holidays, and sick time, and other benefits.
    $106.5k-159.8k yearly Auto-Apply 4d ago
  • Global Quality Manager - CBS

    Amphenol Communication Solutions 4.5company rating

    Quality engineer job in Nashua, NH

    Global Quality Manager (CBS) Green, Nashua, Mexicali, Nantong, Hanoi) Amphenol Cable Backplane Systems (CBS) operates at an extreme pace with rapid growth, driven by the global AI hardware infrastructure expansion. As the leading supplier of complex cabled backplane systems, CBS enables next-generation data center performance for technology titans. Our solutions involve thousands of twin-ax subassemblies packaged into custom mechanical assemblies with tightly controlled electrical and mechanical specifications. CBS supports customers from early concept development through full-scale datacenter deployment, ensuring reliability and precision at every stage. The CBS team is looking for a Global Quality Manager. The Global Quality Manager will lead the end-to-end global Quality strategy for Cable Backplane Systems (CBS), ensuring product and process quality across NPI and volume manufacturing, driving customer satisfaction, and reducing field returns through robust prevention, detection, and continuous improvement. Key Responsibilities Strategy & Governance: Define the global Quality Management System (QMS), policies, and KPIs (FPY, DPPM, RMA rate, audit scores). Standardize across sites and suppliers. Customer Quality: Own customer quality interface; lead executive reviews; align on quality agreements and purge/replacement plans; oversee PCNs and SQE engagement. NPI Quality: Embed APQP/PPAP, CTQs, and gated readiness in new programs; drive process capability (Cp/Cpk), measurement systems (MSA), and qualification (DQ/IQ/OQ/PQ). Manufacturing Quality: Deploy SPC, layered process audits, mistake-proofing, and rapid containment; run weekly global quality reviews; ensure compliance to regulatory/industry standards. Problem Solving: Institutionalize 8D root cause and corrective action; lead cross-functional FA on top issues. Supplier Quality: Set SQE/PPM targets; qualify second sources; manage incoming quality and change control (PCNs). Digital Quality: Scale AI vision and analytics playbooks for in-factory reliability and inline detection; build dashboards for real-time quality health. People & Culture: Build and mentor a high-performing global quality team; develop succession and training (SPC, 8D, MSA, FMEA). Qualifications: BS in Engineering (EE/ME/IE) required; MS/MBA preferred. 10-15+ years in Quality leadership across multi-site, high-mix electronics manufacturing (connectors/cables/EMS/semiconductor adjacent). Deep expertise in APQP, PPAP, SPC, MSA, FMEA, DOE, reliability and FA (metrology, microscopy, environmental/electrical tests). Proven track record with Tier-1 customers and ramp/scale scenarios; strong program and stakeholder management. Ability to travel globally (25-40%).
    $107k-128k yearly est. 1d ago
  • Quality Coordinator

    Ksaria Corporation 4.3company rating

    Quality engineer job in Hudson, NH

    The Quality Coordinator will work in the Internal Quality Team on military/ aerospace products. The position will be responsible for activities that effectively identify, manage and report status of products and compliance with applicable regulatory requirements in the Aerospace/Defense Industries. The Quality Coordinator will be assisting the quality team in retrieving all proper documentation needed before product goes to production. This position reports directly to the Quality Supervisor From time to time assist in stockroom with kitting/cut verification of cables Preform inspections of documents in the production area, being sure they are at the required revision levels and ensuring paperwork is filled out correctly and completely Assist the quality team with incoming inspections, documenting per procedure Requirements This is an onsite position Knowledge and experience of various computer applications Detail oriented Must be a US person for US Department of Defense work Familiarity of AS9100 and ISO9000:2001 a plus Attention to detail and asking ‘why' is required Familiar with Military or Medical products/procedures a plus High School Diploma required Technical training in or knowledge of fiber optics a plus Fluency in English (verbal and written). PM19
    $60k-83k yearly est. 37d ago
  • Supplier Quality Engineer

    Solectron Corp 4.8company rating

    Quality engineer job in Hollis, NH

    Job Posting Start Date 12-11-2025 Job Posting End DateFlex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world.A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. If you are excited about a role but don't meet every bullet point, we encourage you to apply and join us to create the extraordinary.Job Summary Farm, a Flex company with over 50 years of experience in providing award-winning development services for medical, life sciences, and consumer healthcare sectors, is seeking a Supplier Qualtiy Engineer in Hollis, NH. The Supplier Quality Engineer is responsible for supporting supplier-related activities on development teams at Farm. He or she ensures that the development team is compliant with the policies and procedures of Farm's quality management system (QMS). The Supplier Quality Engineer receives direction from the Director of Quality and input from Program Managers and program team members. What a typical day looks like: Support product development as an embedded program team member working alongside program managers, researchers, human factors engineers, designers, mechanical engineers, electrical engineers and process engineers. Facilitate selection of suppliers to support late-stage development and clinical builds. Qualify suppliers via capability questionnaires, risk assessment, supplier file creation/management and remote or on-site audits. Represent program team supplier quality requirements during collaboration with procurement and supply chain resources. Develop program supplier and incoming inspection plans for late-stage development and clinical builds based on input from program managers, engineers, suppliers and customers. Plan and support test method and process validation activities completed by suppliers. Complete incoming inspection and management of materials for late-stage development and clinical builds. Manage site non-conforming material review process. Lead supplier-related corrective action and preventive action resolution. Manage site quality management system approved supplier list, supplier files and supplier performance metrics. Establish, evaluate, qualify, encourage use of and continuous improvement to supplier management processes, procedures and standard tools used by program teams. Participate in internal, customer and notified body audits of the quality management system. Interacts with customers, suppliers and external auditors to develop close working relationships. Participates in customer strategy meetings and discussions regarding the development of program quality requirements and plans. Participates in the technical review process on development programs. The experience we're looking to add to our team, Bachelor's degree in engineering, science, or equivalent technical discipline 1+ years of supplier quality experience Analytical thinking, plus verbal and technical writing skills Demonstrated team collaboration experience Previous medical device industry experience/ ISO13485 (prefer) What you'll receive for the great work you provide: Full range of medical, dental, and vision plans Life Insurance Short-term and Long-term Disability Matching 401(k) Contributions Vacation and Paid Sick Time Tuition Reimbursement Job CategoryQualityRelocation: Eligible for domestic relocation only Is Sponsorship Available? NoFlex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We do not discriminate based on: age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status, or any other status protected by law. We're happy to provide reasonable accommodations to those with a disability for assistance in the application process. Please email accessibility@flex.com and we'll discuss your specific situation and next steps (NOTE: this email does not accept or consider resumes or applications. This is only for disability assistance. To be considered for a position at Flex, you must complete the application process first).
    $80k-102k yearly est. Auto-Apply 41d ago
  • Quality Manager

    St. Joseph Hospital Nashua 4.4company rating

    Quality engineer job in Nashua, NH

    Essential Duties and Responsibilities Supports and promotes the mission and values of Covenant Health Ministry. Supports and leads team in the accreditation and certification programs. Applies time management and flexibility to meet the needs of the organization. Analyzes and reports quality data internally and externally. Uses analytical data management skills to promote patient safety and performance improvements. Facilitates meetings and multidisciplinary teams to ensure participation of team facilitation skills and change management processes to engage others in support of the changes required to achieve performance improvement outcomes. Identifies and mitigates barriers that impede sustainable change. Demonstrates and teaches others the principles of performance improvement. Uses a range of quality improvement tools and techniques to evaluate and successfully redesign processes toward improved performance. Accesses and uses resources to demonstrate current / best practice, identify opportunities for improvement, and leads efforts toward improved outcomes. Advises on future data and information needs and resources to support performance and process improvement initiatives. Participates in DNV Hospital Accreditation, other regulatory surveys, and the hospital's survey readiness program Serves as a partner, teacher, and coach with assigned customer base. Other duties as consistent with this role. If supporting the Primary Stroke Center (PSC) Program: Serves as the DNV PSC subject matter expert Coordinates and facilitates the DNV PCS Survey Facilitates the PSC committee and drives program performance improvement Abstracts chart data or validates third party abstraction and maintains stroke registry Collaborates with education or others to provide stroke-related education Collaborates with the stroke program medical director for community education Maintains nursing competencies, as appropriate. If supporting the Hip and Knee Replacement Program (HKRP): Serves as the DNV HKRP Certification subject matter expert Coordinates and facilitates the DNV Hip HKRC Survey Collaborates Ortho Nurse Navigator to coordinate the HKRP committee Abstracts chart data or validates third party abstraction and maintains HKRP registry Collaborates with education or others to provide HKRP-related education Job Requirements Job Knowledge and Skills Experience with Regulatory and Accrediting bodies. Current computer skills, graphics, spreadsheets, and presentation software. Quantitative and analytic skills relevant to the role. Current knowledge of clinical processes and operations in a health care system Critical thinking and communication skills Project management knowledge and skills Education and Experience NH Registered Nurse license preferred Hospital Quality / Performance Improvement / Patient Safety experience required Five years of clinical experience preferred BS or BA strongly preferred CPHQ certification preferred, or eligible to obtain within 1 year Covenant Health Mission Statement We are a Catholic health ministry, providing healing and care for the whole person, in service to all in our communities. Our Core Values: •Compassion We show respect, caring and sensitivity towards all, honoring the dignity of each person, especially the poor, vulnerable and suffering. •Integrity We promote justice and ethical behavior, and responsibly steward our human, financial and environmental resources. •Collaboration We work in partnership, dialogue and shared purpose to create healthy communities. •Excellence We deliver all services with the highest level of quality, while seeking creative innovation. Applicants, employees and former employees are protected from employment discrimination based on race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), national origin, age (40 or older), disability, and genetic information (including family medical history). Comp Range: $73,014.51 - $109,521.76 Rate of pay displayed reflects the beginning of the pay scale. At the time of an offer, determination of your offer will reflect your skills and experience as it relates to the position. Our people make the difference. See firsthand what makes our employees and culture shine!
    $73k-109.5k yearly Auto-Apply 12d ago
  • Customer Quality Manager

    The Panther Group 3.9company rating

    Quality engineer job in Andover, MA

    Our client, a leading technology manufacturer, is seeking a Quality Specialist with strong technical expertise. This role will focus on managing and improving the return merchandise process, addressing customer product issues, and supporting internal quality efforts. Key Responsibilities: Review and process customer return requests, ensuring compliance with company policies. Provide timely, clear communication to customers regarding return status and resolutions. Support failure analysis of returned products and guide engineering teams in root cause analysis and technical reporting. Collaborate with customer support and engineering teams to resolve field issues. Analyze and report the return request process and performance metrics Work cross-functionally with quality and manufacturing teams to drive corrective and preventive actions. Align quality initiatives with production goals to improve product performance and cost efficiency. Qualifications: Bachelor's degree required; BSEE highly preferred. Minimum 6 years of experience in a technical quality or failure analysis role within electronics manufacturing. Experience working in a fast-paced environment with competing priorities Strong organizational skills with the ability to manage multiple priorities effectively. Excellent interpersonal skills and a collaborative approach.
    $78k-108k yearly est. 60d+ ago
  • Quality Manager

    Terex Corporation 4.2company rating

    Quality engineer job in Watertown Town, MA

    Join our Team: Quality Manager, On-Site Watertown, South Dakota (This leadership role offers full relocation benefits) Join our team at Terex Utilities and embark on an exciting opportunity as we seek a skilled and dedicated Quality Manager to contribute to the Terex Utilities team in Watertown, SD. At Terex we believe in fostering a vibrant and inclusive work culture where every person is empowered to thrive. We're dedicated to driving quality, innovation, embracing diversity, and creating an environment where everyone feels valued and respected. We're committed to excellence in everything we do, and we're seeking talented individuals who share our passion and values to join our team. What you'll do Lead the development, implementation and ongoing maintenance of the Terex Utilities Quality System. Work closely with plant management to incorporate the quality standards and systems within a Lean Manufacturing environment. o Core areas include welding, paint, fiberglass, hydraulics, electrical, and product testing. Implement process changes through engineering, materials, and operations to result in improved quality of business & product. Manage quality program value stream from suppliers through customers. Define KPI's for key metrics throughout tiers in business. Engage with cross-functional teams on a daily basis. Oversee quality lab functions for in house management of calibration, monitoring and measuring systems. Responsibility as ISO Management Representative. What you'll bring Bachelors degree (Engineering degree or MBA preferred) 1 - 5+ years of management or supervisory experience 3 - 5+ years of quality systems experience Manufacturing experience ISO9001 understanding Ability to understand and interpret blueprints and schematics Willingness to work at all levels of the organization to include office and shop-floor activities Exceptional communication skills. Additionally, candidate must have the ability to communicate effectively with customers about quality issues and initiatives Must have demonstrated leadership experience with cross functional teams Proficient with Microsoft Excel, PPT & Word Knowledge of Lean Manufacturing concepts Excellent problem-solving skills Excellent project management and planning skills Ability to travel approximately 10% of the year Currently resides or is open to relocating to Watertown, SD Why Join Us We are a global company, and our culture is defined by our Values - Integrity, Respect, Improvement, Servant Leadership, Courage, and Citizenship. Check out this video! The Terex purpose Safety is an absolute way of life. We expect all team members to prioritize safety and commit to Zero Harm. Our top priority is creating an inclusive environment where every team member feels safe, supported, and valued. We make a positive impact by providing innovative solutions, engaging our people, and operating in a sustainable way. We are committed to helping team members reach their full potential. Through innovation and collaboration, our vision remains forward-looking, and we aim to be a catalyst for change, inspiring others to build a better world for generations. We offer competitive salaries, health insurance (medical, dental, vision, Rx), life insurance, accidental death & dismemberment (AD&D), short-term and long-term disability, extended leave options, paid time off, company holidays, 401k matching, employee stock purchase plan, legal assistance, wellness programs, tuition reimbursement and discount programs. For more information on why Terex is a great place to work click on the link - Careers | Terex Corporate The compensation range for this position is $98,000 - $145,000 annual salary. Pay is based on several factors including but not limited to education, work experience, certifications, etc. If you are interested in an open position but feel you may not meet all the listed qualifications, we still encourage you to apply. About Terex: Terex Corporation is a global industrial equipment manufacturer of materials processing machinery, waste and recycling solutions, mobile elevating work platforms (MEWPs), and equipment for the electric utility industry. We design, build, and support products used in maintenance, manufacturing, energy, minerals and materials management, construction, waste and recycling, and the entertainment industry. We provide best-in-class lifecycle support to our customers through our global parts and services organization, and offer complementary digital solutions, designed to help our customers maximize their return on their investment. Certain Terex products and solutions enable customers to reduce their impact on the environment including electric and hybrid offerings that deliver quiet and emission-free performance, products that support renewable energy, and products that aid in the recovery of useful materials from various types of waste. Our products are manufactured in North America, Europe, and Asia Pacific and sold worldwide. Additional Information: We are passionate about producing equipment that helps improve the lives of people around the world and providing our team members with a rewarding career and the opportunity to make an impact. We are committed to recruiting, engaging, developing, and retaining team members at all levels of our global workforce. Our culture is defined by our Terex Way Values - Integrity, Respect, Improvement, Servant Leadership, Courage, and Citizenship. Our values are the driving force behind our commitment to maintain an inclusive, supportive, non-discriminatory, and safe workplace for all team members. To that end, we are committed to actively foster a culture where every team member feels valued, listened to, and appreciated. We are committed to being fair and impartial in our decisions. As an Equal Opportunity Employer, employment decisions are made without regard to race, color, religion, national origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. If you are a qualified individual with a disability, including disabled veterans, you may request a reasonable accommodation if you are unable or limited in your ability to access job openings or apply for a job on this site as a result of your disability. You can request reasonable accommodations by contacting the recruiting department (person or department) at ********************************** . The Company offers competitive salaries, advancement opportunities, and a full range of benefits, including paid vacation, 401(k), medical, dental, and vision.
    $98k-145k yearly Auto-Apply 5d ago
  • Quality Manager

    The Timken Company 4.6company rating

    Quality engineer job in Keene, NH

    Your Career Begins at Timken If you're ready for a challenging career that provides you with the ability to advance personally and professionally, look to Timken. Our associates make the world more productive by improving the efficiency and reliability of the machinery that keeps industry in motion. What We Offer: Competitive Pay Comprehensive benefits package, including medical, dental and vision coverage. Benefits start on first day of employment. 401(k) retirement savings plan with generous company match 10 paid holidays per year plus paid vacation. Paid parental leave at one year of service. Employee discounts on products and services. Education expense reimbursement, eligible to apply at first day of employment. Opportunities for professional development and career growth. Position Summary: The Quality Manager should have a diverse knowledge of super precision ball bearings, familiarity with Aerospace and DOD applications a plus, and a diverse knowledge of the unique specifications and gauging methods for each type of product to ensure compliance to Timken and customer specific requirements. The manager should have some background with CMM gaging and experience applying this technology and programming in a job shop environment with over 7000 SKU's. The Quality Manager is responsible for the plant's quality management system (QMS) and associated metrology equipment for the plant. Essential Responsibilities: Customer Satisfaction: Accountable for establishing the system for product quality appraisals in the manufacturing process to meet internal specifications and global customer expectations. Must communicate with internal sales and service engineers as they interface with customers. Responsible for responding to customer complaints in a timely manner. Manage rework operations and required customer documentation. Possess general manufacturing and application knowledge of miniature precision ball bearings. Coordinates customer PPAPs & FAI's. Manage all product and process audits to ensure compliance, including customer audits, internal quality audits, and outgoing quality audits. Quality Management System: Responsible for attaining and maintaining quality certifications and communicating with the 3rd party registrar. This includes NADCAP and AS9100 certifications. Responsible for maintaining all metrology methods and calibrations. Responsible for the metallurgical integrity of the plant's heat treat process, including quality systems concerning product metallurgy. Responsible for implementing and maintaining all aspects of the Timken Quality Management System (TQMS) and implementing the modules as required. Supplier Quality Responsible for assuring incoming product quality. Works with corporate Supplier Development to assure suppliers maintain a quality system and proper controls during the manufactuing of the product. Works with corporate Supplier Development to resolve quality issues/complaints with suppliers, while balancing the risk to our customers and to the supply chain. Continuous Improvement Manage and direct quality related continuous improvement to reduce scrap and lower operations costs. Coordinates machine and gaging capability studies while making recommendations for continuous improvement as a result of these studies Metrology Responsible for maintenance, certification, calibration, and availability of all CMMs, “hard” gauges, electronic gauges and product masters required. General Responsibilities Responsible for the training and development of team members in the Quality Dept. Lead Management team in review of plant quality metrics and promote the use of disciplined problem-solving techniques and corrective action to drive continuous improvement in all areas of the plant Basic Qualifications: Bachelor's degree in engineering, materials, management or another technical field Minimum 3-5 years' experience in a manufacturing environment Experience developing and maintaining quality management systems - including metrology and SPC. Excellent written and oral communication skills. Experience interacting with suppliers and customers. Excellent computer skills and ability to analyze data. Preferred Qualifications: ASQ: Certified Quality Engineer, Certified Quality Auditor and/or Certified Quality Manager Masters Degree Shainin or Six-Sigma Certification. Experience in project management. Experience managing a QMS. Experience in metal working - including machining, heat treating, grinding, and assembly. Experience with quality systems in a NADCAP and/or AS9100 certified plan. Location: Timken, Keene, NH Job Type: Full-Time Shift: Day Shift Salary Range: $98,000.00- $140,000.00 All qualified applicants shall be treated equally according to their individual qualifications, abilities, experiences and other employment standards. There will be no discrimination due to gender or gender identity, race, religion, color, national origin, ancestry, age, disability, sexual orientation, veteran/military status or any other basis protected by applicable law.
    $98k-140k yearly 60d+ ago
  • Sr Quality Systems Specialist

    Hologic 4.4company rating

    Quality engineer job in Marlborough, MA

    Newark, DE, United States Marlborough, MA, United States Hologic is seeking a **Senior Quality Systems Specialist** to strengthen and sustain our Quality Management System (QMS) and quality operations. In this role, you'll work across engineering, supply chain, regulatory, marketing, and other functions to investigate process, product, and system issues, support audits and inspections, and help develop and refine quality procedures. You'll use data-driven tools to analyze trends, support continuous improvement, and ensure our systems are audit-ready. If you enjoy solving diverse quality challenges, partnering cross-functionally, and owning impactful quality system initiatives in a regulated environment, this role is a strong fit. Knowledge + Working understanding of Quality Management Systems (QMS), especially Management Review, Quality System audits, CAPA, nonconformances, and quality planning. + Knowledge and experience with ISO 13485, MDSAP, EU MDR, and 21 CFR 820/QMSR in a medical device or IVD environment. + Familiarity with internal and external audit expectations and documentation needs (front-room/back-room). + Understanding of GMP concepts and quality system processes such as Quality Agreements, Quality Plans (QPLs), and Periodic Review. + Beneficial: Basic understanding of statistics and statistical analysis for quality metrics and KPIs. + Beneficial: Experience with Agile or equivalent PLM systems. Skills + Excellent computer skills, including use of word processing, spreadsheet, and database applications (data entry, querying, and report generation). + Strong technical writing skills for drafting procedures, quality system documentation, audit responses, and investigation reports. + Ability to apply auditing knowledge to help build robust, audit-ready systems and documentation. + Experience with Quality Management Systems, particularly Management Review, CAPA, and quality system audits. + Capable of documenting technical work and leading/assisting investigations and improvements in a GMP-regulated environment. + Able to modify, maintain, and create procedures and processes related to QMS elements. + Comfortable presenting materials and quality system status to director-level leadership. + Strong interpersonal skills to collaborate with junior staff, peers, and senior stakeholders across the organization. Behaviors + Models Hologic's quality values, promoting defect prevention, reduction of variation and waste, and continuous improvement. + Detail-oriented and thorough, ensuring quality records, procedures, and outputs are accurate and compliant. + Collaborative and communication-focused, working effectively with cross-functional teams at all levels. + Uses sound judgment in selecting methods and techniques to solve diverse quality system problems. + Proactive and self-directed, requiring little day-to-day instruction while responding effectively to new assignments. + Comfortable networking with senior internal and external personnel within area of expertise. Experience + College Degree required; Technical Bachelor's Degree preferred (e.g., Engineering, Life Sciences, or related field). With a non-technical college degree: 3-5 years in the medical device or IVD industry. Or with a technical Bachelor's degree: 2-4 years of experience; 1-3 years with a Master's degree. + Experience in a certified medical device or pharmaceutical manufacturing environment. + Hands-on experience with QMS elements such as Management Review, audits, CAPA, and quality planning. + Experience supporting internal and external audits and/or FDA inspections 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 $85,200-$133,300 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
    $85.2k-133.3k yearly 5d ago
  • Clinical Quality Program Manager

    Mass General Brigham

    Quality engineer job in Somerville, MA

    Site: Mass General Brigham Health Plan Holding Company, Inc. Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. Job Summary Responsible for overseeing and improving clinical performance metrics and ensuring compliance with healthcare regulations and accreditation standards. Collaborates with clinical teams to develop strategies for improving patient care outcomes and ensures that clinical operations align with regulatory and quality requirements. Essential Functions -Monitor and analyze clinical performance data to identify areas for improvement in patient care and outcomes. -Ensure compliance with all regulatory, accreditation, and quality standards across clinical operations. -Collaborate with clinical staff to implement performance improvement initiatives and ensure best practices in patient care. -Develop and maintain clinical performance dashboards and reports to track key metrics. -Coordinate with quality, compliance, and risk management teams to ensure alignment with organizational goals. -Provide training and education to clinical teams on performance improvement, regulatory compliance, and accreditation standards. -Conduct audits and assessments of clinical processes to ensure continuous quality improvement. -Work with leadership to set performance goals and develop action plans to achieve them. Qualifications Education Bachelor's Degree required; work experience can be substituted in lieu of a degree License/Certification Massachusetts Registered Nurse (RN) license highly preferred Experience At least 3-5 years of experience in clinical performance management, compliance, or quality improvement required Knowledge, Skills, and Abilities Knowledge of healthcare regulations, accreditation standards (e.g., Joint Commission), and clinical performance metrics. Strong analytical skills with the ability to interpret clinical data and identify improvement opportunities. Excellent communication and collaboration skills to work effectively with clinical teams and leadership. Detail-oriented with a strong understanding of healthcare regulations and accreditation standards. Proficiency in performance management software and tools for tracking clinical outcomes. Ability to lead performance improvement projects and implement evidence-based practices. Additional Job Details (if applicable) Working Conditions This is a remote role that can be done from most US states Remote Type Remote Work Location 399 Revolution Drive Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $78,000.00 - $113,453.60/Annual Grade 7 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: Mass General Brigham Health Plan Holding Company, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.
    $78k-113.5k yearly Auto-Apply 30d ago
  • Staff Product Quality Engineer

    Vulcanforms

    Quality engineer job in Devens, MA

    Job Purpose The Staff Product Quality Engineer plays a hands-on role in driving product quality and regulatory compliance throughout the development and production of advanced metal additive manufactured components. This role is critical in building scalable, quality-focused processes that enable efficient production of high-performance parts, from prototyping through full-scale production. Working cross-functionally with R&D, Manufacturing, Operations, suppliers and customers, the Staff Product Quality Engineer will lead quality initiatives, process validations, and continuous improvement efforts, ensuring that products meet rigorous quality, reliability and regulatory standards. Key Responsibilities Partner closely with R&D, Manufacturing and Operations to integrate quality controls from design through manufacturing, ensuring product designs are manufacturable at scale with minimal defects and meet customer and regulatory requirements. Serve as a core Quality team member during new product development and introduction activities, with focus on metrology and metallurgical testing. Provide hands-on support to manufacturing lines, driving root cause investigations and implementing effective corrective and preventive actions to resolve product and process quality issues. Promote awareness of Quality and Regulatory requirements across teams to ensure compliance with internal Quality Management System standards and external regulations (e.g., ASTM standards for Ti-6Al-4V). Set up and validate metrology inspection methods and mechanical/metallurgical testing protocols, including operator training. Develop and implement Statistical Process Control (SPC) and lead validation/verification of new and existing products and processes. Develop and maintain key quality system documentation including Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), change orders, and Master Validation Plans. Serve as a Material Review Board team member to evaluate and disposition of non-conformances. Investigate escalated product complaints to root cause and drive timely resolution. Monitor product and process performance metrics and act upon trends to drive continuous improvement to improve product quality and operational efficiency. Support supplier quality activities, including qualification audits, as a subject matter expert and ensure supplier materials meet quality criteria. Collaborate with suppliers and customers to address and resolve quality issues. Develop and implement quality control strategies for Ti-6Al-4V additive manufacturing processes; Establish and validate metallurgical test equipment for titanium alloys (e.g., Ti-6Al-4V), including tensile, hardness, density, and microstructure evaluations. Lead quality engineering projects, working across manufacturing engineering, operations quality control, metallurgical lab, and NPI teams, to develop and implement quality process controls to ensure compliance with AS9100, ISO 9001, and ISO 13485 standards. Qualifications Bachelor's degree in Engineering, Mechanical Engineering, Materials Science, Quality, or related field preferred; equivalent hands-on experience will also be considered. 6+ years of quality engineering experience, ideally in advanced manufacturing or additive manufacturing environments. Strong knowledge of quality system standards and regulatory compliance, including GMP, FDA QSR, and ISO 13485. Proven experience with process validation, root cause analysis, data analysis, statistical process control (SPC), and corrective action implementation. Hands-on experience with titanium alloys (e.g., Ti-6Al-4V) additive manufacturing processes is a strong plus. Strong organizational, analytical, and problem-solving skills in a manufacturing environment. Proficiency in metrology techniques and mechanical/metallurgical testing methods. Demonstrated ability to lead cross-functional projects, influence stakeholders, and drive quality initiatives from concept through production. Excellent communication skills with experience interfacing with suppliers and customers. Lean, Six Sigma, or similar continuous improvement certification is a plus. VulcanForms offers a competitive salary and equity package. Actual compensation is based on factors such as the candidate's skills, qualifications, and experience. In addition, VulcanForms provides comprehensive benefits including medical, dental, vision, and life insurance; generous paid time off; and a 401(k) plan with company match. The annual base salary range for this position is $1 28,000-$176,000.
    $176k yearly 60d+ ago
  • Quality Technician

    Granite State Manufacturing 3.9company rating

    Quality engineer job in Manchester, NH

    Supports Quality Assurance and Control activities to ensure products and procedures meet all applicable internal and external requirements. Supports the administration and maintenance of quality systems. Provides support for quality projects dictated by the Quality Leadership. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES Supports the administration and maintenance of in-process inspection reports, final inspection reports, and First Article inspection Reports compliant with AS9102 using Discus inspection report software. Maintain calibrated test equipment, ensures equipment is calibrated, validated and maintained properly, maintains the calibration system, prepare test data, and identify areas for improvement. Reads and interprets work instructions and to determine dimensions and tolerances. Reads blueprints or specifications to determine dimensions and tolerances. Collates test data and drafts quality reports. May interpret test results and compare them to the specifications and control limits in place while providing recommendations on the appropriateness of data. Supports QMS activities including but not limited to CAPA, Internal Audits, Document Control, Records Management, etc. Maintain QMS documentation; revise and update documentation, assign training based on documentation changes. May interpret Geometric Dimensioning & Tolerance Strong attention to detail, organization, and documentation skills. May verify specified dimensions of product or raw material using verniers, micrometers, CMM, height gages, comparator, scales or other tools. Assists in other areas in support of product conformity. Demonstrates responsibility and accountability for creating a professional, safe, and clean environment evidenced by: being at work on time to perform assigned duties, following the policies of Granite State Manufacturing, always wearing safety glasses in designated areas, maintaining a neat and orderly work area, and following safety practices to prevent errors. Demonstrates commitment to teamwork by establishing effective relationships and networks with both managers/directors and workers and collaborating with them to accomplish shared purposes and goals. Complies with federal and state laws, regulations, specifications and company standards. Abides by GSM Code of Ethics and Business Conduct standards and strictly observes all U.S. and foreign laws and regulations. Requirements QUALIFICATIONS, SKILLS, AND ABILITIES Two-year certification from college or technical school; or ASQ Certified Quality Technician; or 4 years related experience and/or training; or equivalent combination of education and experience. Experience as an inspector or quality technician. Experience working with quality management systems, should know how to interpret Geometric Dimensioning & Tolerance. Must have the ability to work as a team player in a group or team environment and must be able to work independently without supervision. Comfortable using Microsoft Office (Excel, Word, Outlook, PowerPoint) or similar software. Preference for experience in aerospace, defense, other regulated manufacturing environments; experience working with NAVSEA is highly desirable. BENEFICIAL SKILL OR EXPERIENCE Advanced skills in Word and Excel. Strong technical writing skills: ability to create or update procedures and work instructions. Experience operating and setting up CMM's and Faro arms beneficial but not required. Advanced knowledge of inspection, plating and coating processes, and raw materials a plus. A personal and professional background sufficient to secure Government Security Clearance. AAP/EEO STATEMENT Granite State Manufacturing (GSM) is an affirmative action and equal opportunity employer. GSM does not discriminate on the basis of race, color, religion, sex, gender, gender identity or expression, national origin, citizenship, veteran status, age, physical or mental disability, genetic information, marital status, sexual orientation, or any other consideration made unlawful by applicable federal, state, or local laws in its programs, activities, or employment. Benefits Paid time off Floating holidays Paid holidays 401(k) 401(k) company matching Dental & Vision insurance (Company paid) Employee assistance program Flexible spending account Competitive health insurance Health savings account Life insurance Referral program
    $28k-36k yearly est. Auto-Apply 48d ago
  • Part-Time Quality Technician

    Spindrift 4.3company rating

    Quality engineer job in Newton, MA

    At Spindrift, we're making every beverage a positive force of nature. Founded in 2010, we believe the best flavors come directly from nature. That's why every Spindrift beverage is made the hard way-with real squeezed fruit, never from concentrate. From sourcing the best-tasting fruit globally to maintaining a carefully honed manufacturing process, we believe in doing things the hard way, the intentional way, the better albeit more challenging way, the right way - because, in the end, it's worth it. Spindrift sparkling water is available nationwide, and Spindrift Spiked and Spindrift SODA is available in select markets. We are also a proud member of 1% for the planet, donating to environmental causes. Spindrift is headquartered in Newton, MA. The Quality Technician Role The Quality Technician will be responsible for supporting the Spindrift quality program across Spindrift's beverage portfolio, assist with maintenance of the retain library, assistance with recruiting and training internal sensory panelists, assist with collecting, synthesizing and archiving data as it relates to quality initiatives. Responsibilities include: Assisting the Sensory Analyst with managing the Spindrift sensory program by supporting new panelist onboarding and training, product retain tastings onsite, raw material evaluations, and standard production retains Assisting with managing the Product Retain Library to ensure it is neatly organized at all times, including maintaining an orderly process of receiving/processing product retains into the library upon arrival and the disposal/removal of out-of-date code samples Supporting the creation and organization of quality documentation (i.e. SOPs, protocols, training documents and more as needed) Collaborating with various teams within operations on the following activities: Finished product releases as needed, including review of finished micro reports and sensory evaluations Production holds as needed, including performing sensory evaluations on finished product and communicating results to relevant parties Assist with qualification of new suppliers, including performing required sensory evaluation of raw materials to determine acceptability for use Data entry and approval for specified raw materials into quality management system Assist with consumer complaint process, to include but not limited to: data entry, sample collection, investigation support Requirements Previous food safety experience, with experience in HACCP, GMP, USDA, or FDA preferred. Previous experience with SQF, ISO, GFCO, and/or FDA audits desirable Excellent verbal and written communication skills Thrives in an entrepreneurial environment and considers no task too small nor too large Consistently demonstrates accuracy, thoroughness and dependability Establishes and maintains effective channels of communications with internal and external contacts Adjusts tasks and focus in accordance with changing deadlines and priorities Available to travel up to 10% Able to work in the Newton, MA office Benefits Hourly rate for this part-time position is $22 - $25 / hour, 24-32 hours per week.
    $22-25 hourly Auto-Apply 60d+ ago
  • Product Quality Engineer II

    Conformis Inc. 4.3company rating

    Quality engineer job in Wilmington, MA

    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
    $83k-107k yearly est. Auto-Apply 60d+ ago

Learn more about quality engineer jobs

How much does a quality engineer earn in Manchester, NH?

The average quality engineer in Manchester, NH earns between $64,000 and $107,000 annually. This compares to the national average quality engineer range of $61,000 to $103,000.

Average quality engineer salary in Manchester, NH

$83,000

What are the biggest employers of Quality Engineers in Manchester, NH?

The biggest employers of Quality Engineers in Manchester, NH are:
  1. Granite State Manufacturing
  2. DEKA Research
  3. BAE Systems
  4. Freudenberg Medical
  5. L3Harris
  6. Eagleburgmann
  7. Insource Design & Manufacturing TEC
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