Quality System Specialist / Senior Quality System Specialist
Quality engineer job in Woburn, MA
Department: Quality Assurance
Vaxess is a NIH and venture-funded company developing a pipeline of next-generation vaccines and therapeutics on the MIMIX platform. With only five minutes of wear-time on the skin, the self-applied MIMIX patch enables up to two weeks of sustained delivery. The platform combines high 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 Quality System Specialist / Senior Quality System Specialist plays a key role in supporting and enhancing Vaxess Technologies' Quality Management System (QMS) to ensure compliance with applicable GMP/GLP standards. This position focuses on maintaining robust electronic quality systems, managing controlled documentation, and supporting the integration of new processes and applications.
Key Responsibilities:
Quality System and Computerized System Oversight
Support quality oversight for computerized systems, including QMS implementation, configuration, validation, and data migration activities.
Assist in launching new or enhanced system functionalities and communicating updates or user guidance to ensure effective adoption.
Collaborate with internal stakeholders and system vendors to ensure integrated processes across modules (Document Control, Training, Equipment, and Material Management).
Troubleshoot and resolve user issues as needed.
Documentation and Record Management
Manage the full lifecycle of controlled documents, including creation, revision, review, approval, distribution, and archival within the electronic document management system (EDMS).
Ensure that controlled documents, such as SOPs, batch records, and specifications, are accurate, current, and compliant with regulatory and internal requirements.
Coordinate document workflows with cross-functional teams to ensure timely completion and alignment with procedural requirements.
Author or revise SOPs, forms, and work instructions supporting quality system and GMP operations.
Training and Compliance Support
Provide training and day-to-day support to employees on document control and system processes.
Serve as a subject matter expert (SME) for document control and computerized systems during internal and external audits and inspections.
Support tracking and reporting of quality metrics (e.g., training completion, document cycle time, CAPA effectiveness) to drive continual improvement.
Qualifications:
Bachelor's degree in Life Sciences, Engineering, or a related discipline preferred; equivalent work experience considered.
2-5 years of experience in a GMP, GLP, or GxP-regulated environment (pharmaceutical, biotechnology, or medical device industry).
Experience with electronic quality management systems (e.g., Enzyme, Greenlight Guru, Veeva, MasterControl, etc.) is strongly preferred.
Familiarity with relevant regulations and standards (21 CFR Parts 210/211/11/820; ISO 9001/13485).
Excellent attention to detail, organization, and communication skills; ability to manage multiple priorities in a dynamic environment.
Collaborative, proactive, and adaptable work style aligned with a fast-paced, innovation-driven company.
Vaxess, a venture-backed life sciences company, is building a team of exceptional people to rapidly advance products on its microneedle array platform. We work closely as a team and thrive in a dynamic, exciting, and engaging work environment. If you're interested in joining the Vaxess team, please submit your CV/resume to
******************
.
POS Quality Engineer
Quality engineer job in Canton, MA
Our client is seeking a POS Quality Engineer to join their team! This position is located in Canton, Massachusetts.
Execute functional testing for the client's POS systems in a lab environment
Validate new POS features, patches, upgrades, and configuration changes
Troubleshoot issues across POS hardware, networking, integrations, and payment systems
Review logs, identify root causes, and escalate defects to internal teams and vendors
Collaborate with vendors delivering POS products to ensure quality and readiness
Support daily version testing, weekly releases, and continuous enhancements
Maintain test cases, regression suites, and documentation
Ramp up on the clients POS systems, environments, and workflows
Execute manual testing independently and efficiently
Understand integration points with kiosk, mobile apps, loyalty, and payments
Build relationships with product, engineering, and vendor teams
Contribute to expanding and maintaining POS test automation frameworks
Improve test coverage, defect identification, and issue resolution speed
Work independently with minimal oversight while communicating affectively
Support performance-related testing for high-volume transaction scenarios
Help streamline testing workflows to support frequent deployments
Desired Skills/Experience:
5+ years of POS Quality Engineering experience
Hands-on experience with any POS system such as: Aloha, Toast, NCR, Oracle Symphony, or other enterprise/custom POS systems
Experience with payment systems such as: VeriFone, kiosk integrations, loyalty platforms, mobile ordering, and web integrations
Strong manual testing proficiency with the ability to execute tests quickly and accurately
Ability to troubleshoot logs, hardware, and light networking issues
Experience collaborating with third-party vendors on POS deliverables
Familiarity with automation frameworks and ability to contribute to automation improvements
Prior experience working in a POS lab environment (devices, staging stores, simulators)
Strong communication, organization, and self-management skills
Benefits:
Medical, Dental, & Vision Insurance Plans
Employee-Owned Profit Sharing (ESOP)
401K offered
The approximate pay range for this position is between $55.00 and $65.00. Please note that the pay range provided is a good faith estimate. Final compensation may vary based on factors including but not limited to background, knowledge, skills, and location. We comply with local wage minimums.
Quality Engineer
Quality engineer job in Billerica, MA
The Manufacturing Quality Engineer will be highly involved in the manufacturing aspects of the business, with an emphasis on Quality. The Quality Engineer will handle multiple projects and tasks throughout product development, product launch, and manufacturing. Additionally, this individual will ensure that product meets quality standards consistent with customer and other regulatory requirements. This role also supports plant activities in customer issues, supplier issues, and initiate corrective actions with an emphasis on process improvement. The mission of the Manufacturing Quality Engineer is to enhance the quality of materials and products through detection, analysis, and correction of conditions leading to nonconformance.
Job Functions:
Support, maintain, and sustain QMS.
Audit processes and products.
Complete first piece inspection activities.
Support incoming inspection and communicate with suppliers regarding SCARS and other issues.
Confer with engineers about the quality assurance of new products and development of procedures and quality requirements.
Develop and update PFMEAs and Control Plans, as necessary.
Assist in resolving customer quality issues.
Investigate nonconformance reports and coordinate corrective / preventive actions.
Perform internal audits and mentor process owners toward improvement.
Participate on improvement teams for safety, quality, or cost.
Collect and analyze internal/external quality data and report.
Perform other duties as assigned to support the advancement of quality systems and operations.
Skills:
Good team player.
Good problem-solving skills.
Effective communication skills.
Strong computer skills and knowledge of MS Office Suite.
Working knowledge of print and specification interpretation.
Required Experience:
BS in Mechanical Engineering, or another technical field.
2+ year experience in Quality or Manufacturing background in diecast or injection molded products.
Hands on experience measuring with various gauges and tools.
Experience in 5S, lean or other continuous improvement methods.
PPAP, QMS, NADCAP, and ISO9001 standards experience
Process Development Engineer - Thermal Processes
Quality engineer job in Northampton, MA
Type: Full-Time - On site $120,000 - 180,000 (dependant on experience) plus full benefits and equity Scale Innovation. Drive Decarbonisation. Engineer the Future. Eleven have been retained by a Start Up Speciality Chemicals business who are pioneering the next generation of Materials technologies that is engineered to solve real-world power and decarbonisation challenges.
We're now seeking a Process Development Engineer specifically with experience working on Thermal Processes to take on scaling up the core production processes.
This a hands-on, on site position, and is central to bridging R&D innovation with commercial readiness. If you thrive on solving complex technical challenges, working with equipment, and seeing your ideas come to life in a real-world environment-we'd love to hear from you.
Key Responsibilities:
Lead the design, sourcing, and installation of pilot-scale processes
Operate, Troubleshoot and resolve process issues
Create and maintain SOPs, P&IDs, change control, and maintenance logs.
Lead or support safety reviews (PHA, MOC), ensuring full EHS compliance.
What We're Looking For
Demonstrable experience in process development, pilot plant engineering, or scale-up.
Bachelor's degree (or higher) in Chemical, Mechanical, or Process Engineering.
Experience working with/ in a high hazardous / Chemical manufacturing environment
Familiarity with PLC systems, DAQ tools and software
If you're a process engineer ready to build, operate, and optimise systems that could change how the world stores power-apply now and be part of something truly transformative.
Hardware/System Sustaining Engineer
Quality engineer job in Milford, MA
Job Title: Hardware/System Sustaining Engineer
Details:
Type: On-site
Duration: Permanent Direct Hire
Salary: $ Depending on Experience
The Hardware Sustaining Engineer is responsible for supporting, maintaining, and improving existing hardware products throughout their lifecycle. This role bridges design engineering, component engineering, manufacturing, and quality to ensure product reliability, manufacturability, and continued compliance with standards. The role involves diagnosing hardware/system issues, instituting design updates, and designing and implementing automated product test applications.
Key Responsibilities:
Product Support & Maintenance
Provide engineering support for released hardware products across their lifecycle.
Investigate, troubleshoot, and resolve hardware failures in production, field, and customer environments.
Develop and implement engineering change orders / product change notices (PCNs) to address design improvements, manufacturing improvements, and component obsolescence.
Support supply chain in evaluating alternate components and managing end-of-life (EOL) parts.
Manufacturing & Quality Interface
Collaborate with manufacturing teams to resolve build and test issues.
Support failure analysis, root cause identification, and corrective/preventive actions (CAPA).
Work with design engineering and quality teams to maintain compliance with applicable safety, regulatory, and industry standards.
Product Documentation
Maintain and update design documentation, schematics, BOMs, and test procedures.
Validate and verify design changes through lab testing and simulations.
Define test plans for verification of new designs.
Qualifications:
Bachelor's degree in Electrical Engineering, Computer Engineering, or related field.
3-7 years of experience in hardware design, sustaining engineering, or manufacturing support.
Strong knowledge of analog/digital electronics, PCB design, and system-level troubleshooting.
Experience with lab equipment (oscilloscopes, logic analyzers, power analyzers, etc.).
Familiarity with industry standards (UL, FCC, CE, ISO, etc.).
Strong problem-solving and root-cause analysis skills.
Excellent communication skills for cross-team collaboration and reporting.
Preferred Skills:
Experience with Python and manufacturing test scripting.
Experience conducting DVT and reliability testing.
Knowledge of supply chain and component lifecycle management.
Hands-on experience with CAD tools (e.g., Altium, OrCAD) and PLM systems.
Ability to work in fast-paced, cross-disciplinary environments.
Compliance / Export Control:
This position may include access to technology and/or software source code subject to U.S. export controls (including ITAR). Applicants will be required to provide information regarding citizenship/immigration status for compliance. The company may decline to proceed if authorization is required and cannot be obtained.
Company Overview:
Founded in 2010, Top Prospect Group was created with a focus on matching high-quality candidates with top clients while fostering an environment where success is shared by all. In 2023, the company was acquired by HW Staffing Solutions, expanding its service offerings to include technology and professional services.
Qualified candidates are encouraged to apply immediately!
Please include a clean copy of your resume, salary expectations, and any references in your application
.
Manufacturing Engineer
Quality engineer job in Ayer, MA
*Ensures maximum cost effectiveness and reliability of Gerotor manufacturing processes and workflow. Determines the methods and sequence of manufacturing operations for products and machine parts and assemblies; ensures that products and processes meet customer quality requirements. Provides producibility input and manufacturing plans for product design or modification.
Essential Functions:
* Evaluates manufacturing processes by conducting process analysis, applying knowledge of product design, fabrication, assembly, tooling, and materials, conferring with suppliers, and soliciting observations from operators/production technicians.
* Performs problem solving and root cause analysis of manufacturing issues. Recommends and implements effective corrective actions.
* Develops manufacturing processes by studying product requirements; researching, designing, modifying, and testing manufacturing methods and equipment; and conferring with equipment suppliers. Prepares written and graphical work instructions for the communication of manufacturing requirements to production personnel.
* Improves manufacturing efficiency by analyzing and planning workflow, space requirements, and equipment layout. Assures process control and reliability for assigned area(s).
* Assures product and process quality by designing testing and inspection methods, testing finished product and process capabilities, and establishing standards to confirm and validate manufacturing process requirements.
* Recommends changes to refine and enhance products and processes by applying continuous improvement and key lean manufacturing/production principles and techniques to areas of production.
* Provides manufacturing decision-making information by calculating production, labor standards, and material costs, reviewing production schedules, and estimating future requirements. May provide on-site support to address technical issues at supplier base.
* Prepares product and process reports by collecting, analyzing, and summarizing information and trends.
* May provide concurrent engineering support and recommend manufacturing methods to the engineering design team.
* May keep equipment operational by coordinating maintenance and repair services, following manufacturer's instructions and established procedures, and requesting special service.
* May maintain product and process database by writing computer programs and entering data.
* Maintains professional and technical knowledge by attending educational workshops, reviewing publications, establishing industry networks, benchmarking state-of-the-art practices, and participating in professional associations.
* Complies with federal, state, and local legal requirements (e.g. environmental, safety, etc.) by studying existing and new legislation, ensuring adherence to requirements, and advising management on needed actions.
* Contributes to team effort by accomplishing related results as needed. Work assignments may include cross-
* functional or project team responsibilities (e.g. continuous improvement).
Qualifications:
* Bachelor's degree (BS) in Manufacturing Engineering or related engineering field.
* Professional entry level position.
* May have limited prior industry experience or worked with direction in student internship programs.
* Society of Manufacturing Engineering (SME) or Mechanical Engineering (ASME) certification desired.
* Fundamental knowledge of metallurgy and heat treatment of common aerospace materials.
* Fundamental knowledge of lean manufacturing/production principles and techniques.
* General knowledge of aerospace industry or similar industry products and legal and regulatory requirements related to manufacturing plants. Ability to use standard business applications software and/or specialized data analysis tools.
* May be required to develop skills in drafting, programming, and CAD or other computer aided manufacturing systems.
* Ability to research and analyze data and develop recommendations or resolve problems.
* Ability to work with only general work direction and instructions regarding the scope of assignments, determine priority and order of assignments.
* Ability to read, analyze, and interpret technical journals and reports.
* Ability to respond to inquiries or complaints from team members, team leaders, customers, and regulatory agencies.
* Ability to define problems, collect data, establish facts, and draw valid conclusions.
* Ability to effectively demonstrate team member competencies and participate in goal-setting, performance feedback, and self-development activities.
Process Engineers
Quality engineer job in Boston, MA
Nationwide Opportunities Do you thrive on optimizing systems, improving yields, and driving operational excellence? Whether your background is in pharma, biotech, medical device, or advanced manufacturing, we'd love to connect. At Scientific Search, we partner with industry leaders and emerging innovators across the U.S. who rely on talented Process Engineers to enhance production efficiency, scale technologies, and ensure consistent product quality. We're continually supporting new searches and always expanding our network of process professionals.
We're Interested In Connecting With Engineers Experienced In
Process development, scale-up, and optimization
Equipment design, installation, and validation
Root cause analysis, troubleshooting, and continuous improvement (Six Sigma, Lean)
cGMP manufacturing support within regulated environments
Cross-functional collaboration with operations, quality, and R&D teams
If you'd like to be considered for future Process Engineer roles, please send us your resume. We'll keep you in mind as new positions arise that fit your expertise, interests, and preferred locations.
Submit your resume
We're always growing our network of skilled Process Engineers - let's stay connected so we can help you discover the right opportunity when the time is right. #19580
Engineer III - NPI Manufacturing
Quality engineer job in Andover, MA
Title: Engineer III - NPI Manufacturing
Duration: 6 months+ (possible extension)
Shift: Monday-Friday (8:00 am- 5pm)
Responsibilities:
Lead PFMEA activities in coordination with product development, quality, and manufacturing engineering teams.
Participate in DFM and DFA activities to define manufacturing processes for new product and product enhancement programs.
Develop manufacturing assembly and test methods to ensure Critical to Quality (CTQ) requirements are met.
Must haves:
Bachelors Degree at a Minimum
Only Candidates with a Medical Device Background
5+ years of experience working in an FDA/ISO regulated medical device/medical equipment manufacturing environment.
Must have prior NPI Manufacturing and/or Process Development experience, including disposables and capital equipment.
Test Method Validation and Verification (TMV, V&V)
Manufacturing Engineer I (Andover, MA)
Quality engineer job in Andover, MA
JOIN AN INDUSTRY LEADER! Quality First & Green Always.
Sloan is the world's leading manufacturer of commercial plumbing systems and has been in operation since 1906. We are at the forefront of the green building movement and provide sustainable restroom solutions. We manufacture water- efficient products including flush valves, electronic faucets, soap dispensing and sink systems along with vitreous china fixtures for commercial, industrial and institutional markets worldwide.
We are seeking a Manufacturing Engineer I based out of our Andover, MA location that will report to the Manufacturing Engineer Manager. The Manufacturing Engineer I will plan and design our manufacturing processes. This role will also be responsible for maximizing the overall efficiency by analyzing layout of equipment, workflow, assembly methods, and work force utilization. They will also determine parts and tools needed in order to achieve manufacturing goals according to product specification.
What you'll do:
Developing, controlling and maintaining the manufacturing production process including controlling the design and procuring of fixtures, tooling, capital equipment.
General production floor support including maintain production floor equipment.
Responsible for continuous process improvement tracked by quality yields and standard labor costs.
Creating and maintaining visual aides, maintenance records, procedures and other documents.
Preform time studies on new and existing product line.
Training supervisors group leaders and operators in any new processes or products.
Organizing production floor builds for engineering/prototypes.
Other duties and responsibilities as required.
What we're looking for:
Bachelor's Degree in Engineering or Science
1+ Years Relevant Experience
Ability to trouble shoot problems with production process parts, and equipment, Fixture Design, Word, Excel, CAD System, Versatile. Strong oral and written communication systems.
Ability to apply mathematical concepts to practical situations.
A plus, but not required:
SAP, Lean, Six Sigma background knowledge.
Why you'll love working here:
Inclusive Culture: YOU Belong at Sloan. At Sloan, we are committed to fostering an inclusive and diverse workplace where diverse backgrounds and perspectives are embraced and celebrated. We proudly offer equal employment opportunities regardless of race, color, religion, sex, sexual orientation, gender identity and expression, national origin, disability, age, genetic information, marital status, political affiliation, veteran status, or any other characteristic protected by law.
Growth Opportunities: We invest in our employees' professional development with ongoing training and career advancement opportunities.
Innovative Projects: Be part of exciting projects that push the boundaries of technology and have make a real difference in the world.
Compensation:
The compensation range for this U.S.-based position is $
85,552 - $95,058
annually.
Our compensation range reflects our good faith estimate of what an ideal candidate can expect, but final agreed upon compensation will always be based on the individual candidate's experience, skills, qualifications, and other job-related or market factors that may prove relevant during the hiring process.
Benefits:
Comprehensive Health Coverage: Medical (including prescription coverage), Dental, and Vision Insurance, effective the first of the month following your hire date.
Health Savings Account (HSA): With company contributions for most medical plan options.
Financial Security: Basic Life, Basic Accidental Death and Dismemberment, Short-term Disability, Long-term Disability, and Accident Insurance.
Additional Protection: Optional Life, Critical Illness, Hospital Indemnity, Legal, Pet Insurance, and Identity Theft Protection.
Convenient Commuter Benefits: Save on your daily commute.
Flexible Spending Accounts: Dependent Care FSA to help manage your expenses.
Wellness Support: Employee Assistance Plan and Wellness Programs to keep you healthy and happy.
Retirement Savings: 401(k) Retirement Savings Plan with a company match and immediate vesting.
Generous Time Off: Paid Holidays, Volunteer Time Off, Paid Time Off, Sick Leave, Military Leave, Parental Leave, Bereavement Leave, and other paid or unpaid state/local leaves where required.
Work-Life Balance: Hybrid Work Program to support your flexibility.
Employee Referral Program: Earn rewards for referring great talent.
Professional Development: Tuition Reimbursement Program to help you grow your skills.
Community and Networking: Join our Employee Business Groups and connect with colleagues.
We Are Proud Partners With The Chicago Cubs
We are a Legacy Partner of the Chicago Cubs and we are proud to be the organization's official water efficiency partner! Through this relationship, which includes the naming rights to Sloan Park, the Cubs' Spring Training facility in Mesa, Arizona, we have had the opportunity to promote our brand and continue our water conservation efforts in the city of Chicago and around the world.
JOIN AN INDUSTRY LEADER!
For additional company information please visit our website at *************
We Are An Equal Opportunity Employer.
FM Approvals Research Campus Engineering Technician - Materials
Quality engineer job in Glocester, RI
FM Approvals is an international leader in third-party testing and certification services. We test property loss prevention products and services-for use in commercial and industrial facilities-to verify they meet rigorous loss prevention standards of quality, technical integrity and performance. How? By employing a worldwide certification process that's backed by scientific research and testing, and over a century of experience.
The FM APPROVED mark is recognized and respected worldwide. Our certification instills confidence and commands respect in your marketplace.
Perform assigned tests, investigations or experiments. This may require minor modifications in test setups or procedures as well as subjective judgments in measurement.
Selects, sets up, and operates standard test equipment and records technically sound test data within budgetary and time constraints. Fabricate and construct necessary testing apparatus from existing components. Set-up and tear-down operations for routine investigations and tests.
Trouble-shoot all problems and take corrective actions. Use specialized equipment and apparatus to collect data, calculate or record results, prepare reports and/or technical data. Prepare and present clear and concise data in a prescribed format.
Provide requested advice in areas of specialization to superiors and peers and technical directions to subordinates. Increase your knowledge of testing procedures and related technological advances so as to contribute to personal development and the achievement of personal and unit goals and objectives. Keep the supervisor informed of the status and progress of all work in process and of any significant developments affecting assigned projects.
Education: High School / Trade School or Military specialist experience
Experience (Eng Tech): 3 years general construction and 1 year laboratory experience ideal
Skills/Knowledge: Laboratory testing, product assembly, equipment repair, mathematical computation or data tabulation, use of laboratory test equipment and computer literacy.
Good mechanical skills with familiarity of common hand tools and power tools, ability to work independently.
Must be able to work while wearing full Firefighter's Turnout gear with SCBA for an extended period of time in a wet and smoky environment
Must be able to obtain certification for using a personal respirator and work while wearing one for an extended period of time in a wet and smoky environment
Excellent communication and customer service skills (both orally and in writing) and the ability to work effectively as a member of a team are required.
Ability to read, write and speak English proficiently.
Ability to understand and follow English instructions
Ability to push, pull, lift and carry up to 50 pounds (unassisted) on a regular basis; up to 75 pounds occasionally.
Ability to safely and efficiently operate power equipment such as: cranes, fork lifts and other material handling devices, use ladders, operate tools such as, but not limited to, table saws, portable saws, hammer drills, screw guns and impact wrenches and be certifiable for the use of a respirator.
Candidate must possess good balance to regularly step on and off equipment and work from ladders and platforms to perform various tasks.
The final salary offer will vary based on geographic location, individual education, skills, and experience. The position is eligible to participate in FM's comprehensive Total Rewards program that includes an incentive plan, generous health and well-being programs, a 401(k) and pension plan, career development opportunities, tuition reimbursement, flexible work, time off allowances and much more.
FM Approvals is an Equal Opportunity Employer and is committed to attracting, developing, and retaining a diverse workforce.
#LI-TA1
Auto-ApplyProgram Manager - Clinical Quality Management (Infectious Disease Bureau)
Quality engineer job in Boston, MA
The Ryan White Dental Program (RWDP) is a comprehensive dental access program for persons living with HIV/AIDS in Massachusetts and Southern New Hampshire, funded under Ryan White Part A and with funds from the Massachusetts Department of Public Health. Services funded are recruitment of dentists and preventive, diagnostic and therapeutic services rendered by licensed dentists and dental hygienists.
Under the supervision of the Director of the Ryan White Dental Program , the Clinical/Quality Management Program Manager of RWDP will be responsible for clinical quality improvement, reviewing eligibility for clients accessing services; providing technical and monitoring assistance to assure dental vendors attain contracted goals & objectives; monthly reporting of program activities; maintaining consistent contact with dental providers and other parties as needed; and working collaboratively with program & fiscal staff to ensure system accountability.
Responsibilities
Review dental treatment plans and history to determine appropriate options for people living with HIV (PLWH) seeking dental care to be reimbursed by the program
Provide initial review of dental claims, including client eligibility, dental billing codes, and prior approvals
Review past billing and client dental records to prevent duplicate or improper billing for services
Monitor monthly prior approval expenditures and assist in reconciliation of payments in coordination with other Dental and BPHC fiscal staff
With the assistance of other RWDP staff, review and update annual Scope of Services documents for dental contracts, including client eligibility, fee schedules, and other requirements
With the assistance of other RWDP staff, develop and update a Standard Operating Procedures (SOP) manual, including policies and procedures for Dental staff, vendors, and clients; the client enrollment process; recruitment of vendors; and reimbursement process for dental services.
Draft and revise quality management plan for the program, including tracking of health and quality of life indicators, dental standards of care, and quality improvement activities
Conduct regular research into the most current dental best practices and disseminate such content to a diverse audience, including HIV service providers and clients
Provide support on presentations to both internal and external stakeholders on the impact of services on the oral health care needs of PLWH
Regularly attend programmatic meetings
Handle communication with clients, dental providers, and others
Perform other duties as required
Senior Product Quality Engineer
Quality engineer job in Marlborough, MA
Marlborough, MA, United States Are you passionate about ensuring the quality and safety of medical devices? At Hologic, we are seeking a Quality Engineer to provide engineering support for on-market medical devices. In this role, you'll lead investigations into post-market feedback and complaints, conduct root cause analyses, and implement corrective or preventive actions to ensure our products meet the highest standards of quality and safety. Collaborating with cross-functional teams, you'll drive product and process improvements while making a meaningful impact on the lives of patients worldwide. If you're a proactive problem-solver with experience in quality, risk management, and engineering, we'd love to have you on our team!
**Knowledge:**
+ Strong understanding of FDA Quality System Regulations, particularly Design Control requirements.
+ In-depth knowledge of ISO 13485, EU Medical Device Regulation, and ISO 14971 (Risk Management).
+ Familiarity with test method validation, root cause failure analysis, and statistical methods.
+ Knowledge of system-level requirements for complex medical devices, including software, electromechanical, and hardware components.
+ Awareness of reliability, electrical safety, sterilization, packaging, and biocompatibility standards.
**Skills:**
+ Proven ability to lead cross-functional teams in conducting investigations and implementing corrective and preventive actions (CAPAs).
+ Strong analytical skills to prioritize complaints and investigations based on risk, data analysis, and strategic impact.
+ Excellent project management skills, including implementing design or process changes, performing testing, and managing change control documentation.
+ Ability to perform independent health risk assessments and present findings to leadership.
+ Effective communication skills to present product quality metrics, root cause analyses, and recommended actions to internal stakeholders and leadership.
+ Strong ability to assess and review written product and project documentation for compliance.
+ Preferred: Experience with verification and validation requirements, design of experiments, and requirements analysis for regulated products.
**Behaviors:**
+ Detail-oriented and committed to maintaining the highest standards of quality and regulatory compliance.
+ Proactive and decisive, with the ability to independently prioritize tasks and resolve conflicts.
+ Collaborative and team-oriented, with a focus on fostering productive working relationships across functions.
+ Problem-solving mindset, focused on identifying root causes and driving effective solutions.
+ Customer-focused, with a commitment to addressing product quality issues and ensuring customer satisfaction.
+ Driven by continuous improvement, with a desire to optimize processes and enhance product quality.
**Experience:**
+ **5+ years** of experience in engineering, preferably in a regulated industry such as medical devices.
+ Hands-on experience with root cause analysis, product development, or R&D.
+ Beneficial experience includes supporting complex medical devices (e.g., software, electromechanical systems) at the system level.
**Education:**
+ Bachelor's degree in Engineering (Mechanical, Electrical, Biomedical, or related field).
**Why join Hologic?**
We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.
The annualized base salary range for this role is $97,600-$152,700 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.
**Agency and Third-Party Recruiter Notice**
_Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered._
**_Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans._**
\#LI-NT1
Product Quality Engineer
Quality engineer job in Wilmington, MA
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
Auto-ApplyAdvanced Quality Engineer I
Quality engineer job in Warwick, RI
Represent quality on design teams and assure that new and sustaining product designs and the processes for manufacturing them meet all Corporate and Divisional requirements with respect to safety and efficacy. Be an active team member and cross-function collaborator on new product development and product sustaining project teams for implantable medical devices. Be an active team member for investigating quality complaints, examining non-conformances and executing CAPAs.
Job Description
We are the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us.
Job Responsibilities: (Primary Duties, Roles, and/or Authorities)
Product Development:
* Provide Technical guidance to Quality Engineers, Quality Technicians, and Inspectors.
* Develop Test Protocols and Final Reports to support Regulatory 510K, PMA, CE mark and International registrations.
* Support Pre-Concept Front End Product Innovation Process activities for new technologies.
* Lead Quality Engineering Projects to improve Quality systems and Procedures.
* Develop design risk assessments, coordinating input from the other Design Sub-team members, and manage overall risk files for devices.
* Develop Final Design Verification Protocols and the subsequent Final Design Verification Reports including an analysis of all data and a decision on design acceptability.
* Develop Design Validation Protocols and the subsequent Design Validation Reports including an analysis of all data and a decision on design acceptability.
* Provide input into the project for all phases of design control documents as defined per Davol's product development process.
* Determine the degree of Biocompatibility testing with assistance from biocompatibility SMEs required as per ISO10993 and company procedures. Co-ordinate the testing and document results.
* Develop or assist in development of inspection and test methods per product specifications.
* Develop test protocols and release a final report on Shelf Life and Stability Studies in support of expiration dating.
* Perform test method validations to ensure accuracy, precision, selectivity, sensitivity, stability, and reproducibility of analytical or physical test methods used to assess the safety and efficacy of devices.
* Develop shelf life and stability test protocols and reports as required.
Process Development:
* Develop and document the Control System for the manufacture of new products including Inspection Plans for the inspection of components, sub-assemblies and final product.
* Support the development of manufacturing control plans for internal and outsourced processes.
* Support (or lead) development of process risk assessments.
* Perform and/or support Process Development Studies to determine the acceptability of new processes or equipment.
* Design and qualify inspection test methods and equipment.
* Provide Quality Engineering Support to outsourced analytical laboratories and manufacturing facilities to ensure compliance with applicable requirements of 21CFR 820, 210, 211; cGMP's, and ISO13485:2003 requirements.
* Lead supplier part qualification activities including mold qualification and DOEs.
* Support Process Transfers to the Production facilities.
Other:
* Organize and generate detailed quality information reports to show trends and the impact of process improvements.
* Support Process Transfers to the production facilities.
* Conduct other Quality Control Projects as assigned by the Manager of Advanced Quality Engineering.
* Support the development and effective implementation of Corrective and Preventive Action Plans to resolve quality non-conformances.
* Perform DOEs and other statistical analyses to support product and process optimization or determine causes of process variation. Initiate corrective actions as required.
* Provide technical support to resolve quality problems in development, pilot, manufacturing or with suppliers as warranted.
* Support goals of the Quality Assurance Department.
* Special projects as assigned.
Education and Experience:
* Bachelor Degree in Engineering or Technical Sciences.
* 2 years minimum experience with Bachelor Degree or 1 years minimum experience with Masters Degree in Quality Engineering or related discipline including design controls, product/process validation, risk management, and technical problem solving.
Knowledge and Skills:
* A high level of competence in Quality Technology including statistical techniques, control charts, sampling plans, Quality costs, design of experiments, correlation and regression, analysis of variance, probability.
* Strong Design Control understanding from concept to launch; especially in post-market activities (including complaints, failure investigations, and CAPAs).
* Applied Knowledge of the requirements of FDA QSR, ISO13485, ISO14971, and ISO 9001.
* Prior experience with combination products and absorbable technologies a plus.
* Proven track record of developing new products that meet customer expectations.
* Prior experience as a quality engineer lead on new product development teams.
* Prior experience interacting with Surgeons preferred.
* Knowledge of statistics and experience with statistical software (e.g. MiniTab), preferred.
* Good oral and written communication skills.
* Approximately 15 - 20% travel may be required.
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit **********************
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.
#earlycareer
Required Skills
Optional Skills
.
Primary Work Location
USA RI - Warwick
Additional Locations
Work Shift
Advanced Quality Engineer I
Quality engineer job in Warwick, RI
SummaryRepresent quality on design teams and assure that new and sustaining product designs and the processes for manufacturing them meet all Corporate and Divisional requirements with respect to safety and efficacy. Be an active team member and cross-function collaborator on new product development and product sustaining project teams for implantable medical devices. Be an active team member for investigating quality complaints, examining non-conformances and executing CAPAs.Job Description
We are the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us.
Job Responsibilities:
(Primary Duties, Roles, and/or Authorities)
Product Development:
Provide Technical guidance to Quality Engineers, Quality Technicians, and Inspectors.
Develop Test Protocols and Final Reports to support Regulatory 510K, PMA, CE mark and International registrations.
Support Pre-Concept Front End Product Innovation Process activities for new technologies.
Lead Quality Engineering Projects to improve Quality systems and Procedures.
Develop design risk assessments, coordinating input from the other Design Sub-team members, and manage overall risk files for devices.
Develop Final Design Verification Protocols and the subsequent Final Design Verification Reports including an analysis of all data and a decision on design acceptability.
Develop Design Validation Protocols and the subsequent Design Validation Reports including an analysis of all data and a decision on design acceptability.
Provide input into the project for all phases of design control documents as defined per Davol's product development process.
Determine the degree of Biocompatibility testing with assistance from biocompatibility SMEs required as per ISO10993 and company procedures. Co-ordinate the testing and document results.
Develop or assist in development of inspection and test methods per product specifications.
Develop test protocols and release a final report on Shelf Life and Stability Studies in support of expiration dating.
Perform test method validations to ensure accuracy, precision, selectivity, sensitivity, stability, and reproducibility of analytical or physical test methods used to assess the safety and efficacy of devices.
Develop shelf life and stability test protocols and reports as required.
Process Development:
Develop and document the Control System for the manufacture of new products including Inspection Plans for the inspection of components, sub-assemblies and final product.
Support the development of manufacturing control plans for internal and outsourced processes.
Support (or lead) development of process risk assessments.
Perform and/or support Process Development Studies to determine the acceptability of new processes or equipment.
Design and qualify inspection test methods and equipment.
Provide Quality Engineering Support to outsourced analytical laboratories and manufacturing facilities to ensure compliance with applicable requirements of 21CFR 820, 210, 211; cGMP's, and ISO13485:2003 requirements.
Lead supplier part qualification activities including mold qualification and DOEs.
Support Process Transfers to the Production facilities.
Other:
Organize and generate detailed quality information reports to show trends and the impact of process improvements.
Support Process Transfers to the production facilities.
Conduct other Quality Control Projects as assigned by the Manager of Advanced Quality Engineering.
Support the development and effective implementation of Corrective and Preventive Action Plans to resolve quality non-conformances.
Perform DOEs and other statistical analyses to support product and process optimization or determine causes of process variation. Initiate corrective actions as required.
Provide technical support to resolve quality problems in development, pilot, manufacturing or with suppliers as warranted.
Support goals of the Quality Assurance Department.
Special projects as assigned.
Education and Experience:
Bachelor Degree in Engineering or Technical Sciences.
2 years minimum experience with Bachelor Degree or 1 years minimum experience with Masters Degree in Quality Engineering or related discipline including design controls, product/process validation, risk management, and technical problem solving.
Knowledge and Skills:
A high level of competence in Quality Technology including statistical techniques, control charts, sampling plans, Quality costs, design of experiments, correlation and regression, analysis of variance, probability.
Strong Design Control understanding from concept to launch; especially in post-market activities (including complaints, failure investigations, and CAPAs).
Applied Knowledge of the requirements of FDA QSR, ISO13485, ISO14971, and ISO 9001.
Prior experience with combination products and absorbable technologies a plus.
Proven track record of developing new products that meet customer expectations.
Prior experience as a quality engineer lead on new product development teams.
Prior experience interacting with Surgeons preferred.
Knowledge of statistics and experience with statistical software (e.g. MiniTab), preferred.
Good oral and written communication skills.
Approximately 15 - 20% travel may be required.
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit **********************
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.
#earlycareer
Required Skills
Optional Skills
.
Primary Work LocationUSA RI - WarwickAdditional LocationsWork Shift
Auto-ApplyProduct Quality Engineer - Airfoil Castings
Quality engineer job in Boston, MA
Are you ready to see your future take flight? At GE Aerospace, we are advancing aviation technologies for today and tomorrow. Your work will contribute to the production of advanced jet engines, components, and integrated systems that power commercial and military aircraft. You'll be part of a team that embraces your drive, your curiosity, and your unique ideas and perspectives. Most importantly, you'll share in our pride and purpose that affects the lives of millions around the world!
The Product Quality Engineer for the Airfoil Castings manufacturing process will drive product qualifications and quality improvements for key performance indicators (KPIs) of suppliers within the Airfoil Castings supply chain including quality plan implementation.
The PQE, will own supplier First Article Inspection results and drive supplier compliance to Source Substantiation Plans or design intent verification. Provide supplier product release direction when part approval cycles are not complete while also being the internal quality focal for those parts. Collaborate with Supplier Quality, Supplier Quality Operations and New Product Introduction / Management of Change teams as required- this collaboration may include onsite visitation.
In this role, you will also understand how the team integrates with other teams outside of Quality to meet short term and long term the business objectives. Demonstrate an in-depth understanding of key business drivers; uses this understanding to accomplish own work. In-depth understanding of how work of own team integrates with other teams and contributes to the area.
**Job Description**
**Roles and Responsibilities**
+ Role is responsible for supplier processes, from initial qualification, maintenance, and necessary improvement driven by business quality needs.
+ Product Quality Engineer will have a technical understanding of engineering drawings and will have the ability to manage suppliers and/or quality projects related projects.
+ Develop in-depth knowledge of a discipline. Use prior experience and acquired expertise to execute functional policy/strategy.
+ Communication with direct colleagues and the business on the status of First Article Inspection and Source Substantiation Plans.
+ Provide onsite support at suppliers, as needed ( **approximately 15% travel** )
+ Collaboration with other Engineering, Quality, and Sourcing functions to ensure joint success
+ Impacts projects, processes, and procedures in own field. The role operates with some autonomy but is focused on execution of activities/provision of advice within an enabling discipline covered by standard functional practices and procedures. Activities require professional judgment but may require more senior levels of guidance.
+ Utilizes technical expertise and judgement to solve problems. Leverages technical skills and analytic thinking required to solve problems. May use multiple internal sources outside of own team to arrive at decisions.
+ Uses high level of judgment to make decisions and handle complex tasks or problems in areas of operational, product management, manufacturing, technology, or engineering. Has ability to assess quality of information given and ask pertinent questions to stakeholders. Able to offer new solutions to problems outside of set parameters and can construct and provide recommendations. Uses multiple internal and some external sources outside of own function to help arrive at a decision.
+ May lead functional teams or projects with minimal resource requirements, risk, and/or complexity. Communicates difficult concepts and may influence others' options on specific topics. May guide others to consider a different point of view.
**Required Qualifications**
+ Bachelor's Degree from an accredited college or university (or a high school diploma/GED with 4 years' experience in Engineering, Materials Science or Quality related roles)
+ Minimum of 3 years of experience in Engineering, Materials Science or Quality related roles
**Desired Characteristics**
+ Demonstrated experience in manufacturing or supplier quality.
+ Strong communication skills.
+ Demonstrated ability to analyze and resolve problems.
+ Ability to document, plan, market, and execute programs.
+ Established project management skills.
+ Demonstrated history of problem solving, root cause and corrective action methodology, data analysis, statistical analysis and quality experience.
+ Humble: respectful, receptive, agile, eager to learn
+ Transparent: shares critical information, speaks with candor, contributes constructively
+ Focused: quick learner, strategically prioritizes work, committed
+ Leadership ability: strong communicator, decision-maker, collaborative
+ Problem solver: analytical-minded, challenges existing processes, critical thinker
+ Demonstrated Airfoil Casting manufacturing knowledge and experience is advantageous to the role.
GE Aerospace offers comprehensive benefits and programs to support your health and, along with programs like HealthAhead, your physical, emotional, financial and social wellbeing. Healthcare benefits include medical, dental, vision, and prescription drug coverage; access to a Health Coach from GE Aerospace; and the Employee Assistance Program, which provides 24/7 confidential assessment, counseling and referral services. Retirement benefits include the GE Aerospace Retirement Savings Plan, a 401(k) savings plan with company matching contributions and company retirement contributions, as well as access to Fidelity resources and planning consultants. Other benefits include tuition assistance, adoption assistance, paid parental leave, disability insurance, life insurance, and paid time-off for vacation or illness.
GE Aerospace (General Electric Company or the Company) and its affiliates each sponsor certain employee benefit plans or programs (i.e., is a "Sponsor"). Each Sponsor reserves the right to terminate, amend, suspend, replace or modify its benefit plans and programs at any time and for any reason, in its sole discretion. No individual has a vested right to any benefit under a Sponsor's welfare benefit plan or program. This document does not create a contract of employment with any individual.
The base pay range for this position is 100,000.00 - 115,000.00. The specific pay offered may be influenced by a variety of factors, including the candidate's experience, education, and skill set. This position is also eligible for an annual discretionary bonus based on a percentage of your base salary/ commission based on the plan. This posting is expected to close on **November 30th, 2025.**
_This role requires access to U.S. export-controlled information. Therefore, employment will be contingent upon the ability to prove that you meet the status of a U.S. Person as one of the following: U.S. lawful permanent resident, U.S. Citizen, have been granted asylee or refugee status (i.e., a protected individual under the Immigration and Naturalization Act, 8 U.S.C. 1324b(a)(3))._
**Additional Information**
GE Aerospace offers a great work environment, professional development, challenging careers, and competitive compensation. GE Aerospace is an Equal Opportunity Employer (****************************************************************************************** . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
GE Aerospace will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
**Relocation Assistance Provided:** No
\#LI-Remote - This is a remote position
GE Aerospace is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
Process Engineer III
Quality engineer job in Woburn, MA
Vaxess is a NIH and venture-funded company developing a pipeline of next-generation vaccines and therapeutics on the MIMIX platform. With only five minutes of wear-time on the skin, the self-applied MIMIX patch enables up to two weeks of sustained delivery. The platform combines high 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.
Research & development at Vaxess is cross-disciplinary, integrating mechanical, industrial, biomedical, and
chemical engineering with chemistry, biology, and human factors to address important unmet medical needs.
We are seeking a talented, collaborative, and highly motivated engineer to join our growing team. This role offers a unique opportunity to build manufacturing capacity from the ground up to bring innovative technology to theglobal vaccine and therapeutic market.
Responsibilities
Characterize and improve manufacturing process unit operations by designing, executing, and analyzing process development experiments; communicate results via written reports and oral presentations to internal and project teams
Support manufacturing scale-up by assessing novel equipment, work flows, analytical techniques/PAT, and process configurations
Support manufacturing operations by incorporating equipment and process improvements within established processes and equipment trains, and by revising manufacturing batch records, SOPs, and other controlled documents to reflect changes; contribute to implementing and maintaining Vaxess' Quality System.
Supervise and mentor junior engineer(s) and technicians, including a direct report
Collaborate closely with cross-functional teams to support product development and manufacturing activities
Qualifications
BS in Mechanical Engineering, Biomedical Engineering, or a related discipline
5 - 7 years of relevant direct R&D experience within the medical device or biopharmaceutical industries;
experience working on combination products is highly desirable
Demonstrated success using empirical and first-principles models to inform and analyze experiments; experience with statistical methodologies and working with large data sets (e.g. Six Sigma, DoEs, multivariate techniques) is a plus
Excellent time and project management skills and proven ability to meet goals and deadlines
Demonstrated abilities to learn new skills and fields, creatively solve challenging technical problems, think independently, and work collaboratively in diverse multidisciplinary teams
Entrepreneurial spirit and drive to positively impact global human health
Vaxess is building a team of exceptional people to rapidly advance product development. We work closely as a team and thrive in a dynamic, exciting, and engaging work environment. If you're interested in joining the Vaxess team, please submit your CV/resume to ******************.
Product Quality Engineer II
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
Auto-ApplyAdvanced Quality Engineer I
Quality engineer job in Warwick, RI
Represent quality on design teams and assure that new and sustaining product designs and the processes for manufacturing them meet all Corporate and Divisional requirements with respect to safety and efficacy. Be an active team member and cross-function collaborator on new product development and product sustaining project teams for implantable medical devices. Be an active team member for investigating quality complaints, examining non-conformances and executing CAPAs.
**Job Description**
We are **the makers of possible**
BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a **maker of possible** with us.
**Job Responsibilities:** _(Primary Duties, Roles, and/or Authorities)_
**Product Development:**
+ Provide Technical guidance to Quality Engineers, Quality Technicians, and Inspectors.
+ Develop Test Protocols and Final Reports to support Regulatory 510K, PMA, CE mark and International registrations.
+ Support Pre-Concept Front End Product Innovation Process activities for new technologies.
+ Lead Quality Engineering Projects to improve Quality systems and Procedures.
+ Develop design risk assessments, coordinating input from the other Design Sub-team members, and manage overall risk files for devices.
+ Develop Final Design Verification Protocols and the subsequent Final Design Verification Reports including an analysis of all data and a decision on design acceptability.
+ Develop Design Validation Protocols and the subsequent Design Validation Reports including an analysis of all data and a decision on design acceptability.
+ Provide input into the project for all phases of design control documents as defined per Davol's product development process.
+ Determine the degree of Biocompatibility testing with assistance from biocompatibility SMEs required as per ISO10993 and company procedures. Co-ordinate the testing and document results.
+ Develop or assist in development of inspection and test methods per product specifications.
+ Develop test protocols and release a final report on Shelf Life and Stability Studies in support of expiration dating.
+ Perform test method validations to ensure accuracy, precision, selectivity, sensitivity, stability, and reproducibility of analytical or physical test methods used to assess the safety and efficacy of devices.
+ Develop shelf life and stability test protocols and reports as required.
**Process Development:**
+ Develop and document the Control System for the manufacture of new products including Inspection Plans for the inspection of components, sub-assemblies and final product.
+ Support the development of manufacturing control plans for internal and outsourced processes.
+ Support (or lead) development of process risk assessments.
+ Perform and/or support Process Development Studies to determine the acceptability of new processes or equipment.
+ Design and qualify inspection test methods and equipment.
+ Provide Quality Engineering Support to outsourced analytical laboratories and manufacturing facilities to ensure compliance with applicable requirements of 21CFR 820, 210, 211; cGMP's, and ISO13485:2003 requirements.
+ Lead supplier part qualification activities including mold qualification and DOEs.
+ Support Process Transfers to the Production facilities.
**Other:**
+ Organize and generate detailed quality information reports to show trends and the impact of process improvements.
+ Support Process Transfers to the production facilities.
+ Conduct other Quality Control Projects as assigned by the Manager of Advanced Quality Engineering.
+ Support the development and effective implementation of Corrective and Preventive Action Plans to resolve quality non-conformances.
+ Perform DOEs and other statistical analyses to support product and process optimization or determine causes of process variation. Initiate corrective actions as required.
+ Provide technical support to resolve quality problems in development, pilot, manufacturing or with suppliers as warranted.
+ Support goals of the Quality Assurance Department.
+ Special projects as assigned.
**Education and Experience:**
+ Bachelor Degree in Engineering or Technical Sciences.
+ 2 years minimum experience with Bachelor Degree or 1 years minimum experience with Masters Degree in Quality Engineering or related discipline including design controls, product/process validation, risk management, and technical problem solving.
**Knowledge and Skills:**
+ A high level of competence in Quality Technology including statistical techniques, control charts, sampling plans, Quality costs, design of experiments, correlation and regression, analysis of variance, probability.
+ Strong Design Control understanding from concept to launch; especially in post-market activities (including complaints, failure investigations, and CAPAs).
+ Applied Knowledge of the requirements of FDA QSR, ISO13485, ISO14971, and ISO 9001.
+ Prior experience with combination products and absorbable technologies a plus.
+ Proven track record of developing new products that meet customer expectations.
+ Prior experience as a quality engineer lead on new product development teams.
+ Prior experience interacting with Surgeons preferred.
+ Knowledge of statistics and experience with statistical software (e.g. MiniTab), preferred.
+ Good oral and written communication skills.
+ Approximately 15 - 20% travel may be required.
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
**Why Join Us?**
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit **********************
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.
\#earlycareer
Required Skills
Optional Skills
.
**Primary Work Location**
USA RI - Warwick
**Additional Locations**
**Work Shift**
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
Product Quality Engineer - Airfoil Castings
Quality engineer job in Providence, RI
Are you ready to see your future take flight? At GE Aerospace, we are advancing aviation technologies for today and tomorrow. Your work will contribute to the production of advanced jet engines, components, and integrated systems that power commercial and military aircraft. You'll be part of a team that embraces your drive, your curiosity, and your unique ideas and perspectives. Most importantly, you'll share in our pride and purpose that affects the lives of millions around the world!
The Product Quality Engineer for the Airfoil Castings manufacturing process will drive product qualifications and quality improvements for key performance indicators (KPIs) of suppliers within the Airfoil Castings supply chain including quality plan implementation.
The PQE, will own supplier First Article Inspection results and drive supplier compliance to Source Substantiation Plans or design intent verification. Provide supplier product release direction when part approval cycles are not complete while also being the internal quality focal for those parts. Collaborate with Supplier Quality, Supplier Quality Operations and New Product Introduction / Management of Change teams as required- this collaboration may include onsite visitation.
In this role, you will also understand how the team integrates with other teams outside of Quality to meet short term and long term the business objectives. Demonstrate an in-depth understanding of key business drivers; uses this understanding to accomplish own work. In-depth understanding of how work of own team integrates with other teams and contributes to the area.
**Job Description**
**Roles and Responsibilities**
+ Role is responsible for supplier processes, from initial qualification, maintenance, and necessary improvement driven by business quality needs.
+ Product Quality Engineer will have a technical understanding of engineering drawings and will have the ability to manage suppliers and/or quality projects related projects.
+ Develop in-depth knowledge of a discipline. Use prior experience and acquired expertise to execute functional policy/strategy.
+ Communication with direct colleagues and the business on the status of First Article Inspection and Source Substantiation Plans.
+ Provide onsite support at suppliers, as needed ( **approximately 15% travel** )
+ Collaboration with other Engineering, Quality, and Sourcing functions to ensure joint success
+ Impacts projects, processes, and procedures in own field. The role operates with some autonomy but is focused on execution of activities/provision of advice within an enabling discipline covered by standard functional practices and procedures. Activities require professional judgment but may require more senior levels of guidance.
+ Utilizes technical expertise and judgement to solve problems. Leverages technical skills and analytic thinking required to solve problems. May use multiple internal sources outside of own team to arrive at decisions.
+ Uses high level of judgment to make decisions and handle complex tasks or problems in areas of operational, product management, manufacturing, technology, or engineering. Has ability to assess quality of information given and ask pertinent questions to stakeholders. Able to offer new solutions to problems outside of set parameters and can construct and provide recommendations. Uses multiple internal and some external sources outside of own function to help arrive at a decision.
+ May lead functional teams or projects with minimal resource requirements, risk, and/or complexity. Communicates difficult concepts and may influence others' options on specific topics. May guide others to consider a different point of view.
**Required Qualifications**
+ Bachelor's Degree from an accredited college or university (or a high school diploma/GED with 4 years' experience in Engineering, Materials Science or Quality related roles)
+ Minimum of 3 years of experience in Engineering, Materials Science or Quality related roles
**Desired Characteristics**
+ Demonstrated experience in manufacturing or supplier quality.
+ Strong communication skills.
+ Demonstrated ability to analyze and resolve problems.
+ Ability to document, plan, market, and execute programs.
+ Established project management skills.
+ Demonstrated history of problem solving, root cause and corrective action methodology, data analysis, statistical analysis and quality experience.
+ Humble: respectful, receptive, agile, eager to learn
+ Transparent: shares critical information, speaks with candor, contributes constructively
+ Focused: quick learner, strategically prioritizes work, committed
+ Leadership ability: strong communicator, decision-maker, collaborative
+ Problem solver: analytical-minded, challenges existing processes, critical thinker
+ Demonstrated Airfoil Casting manufacturing knowledge and experience is advantageous to the role.
GE Aerospace offers comprehensive benefits and programs to support your health and, along with programs like HealthAhead, your physical, emotional, financial and social wellbeing. Healthcare benefits include medical, dental, vision, and prescription drug coverage; access to a Health Coach from GE Aerospace; and the Employee Assistance Program, which provides 24/7 confidential assessment, counseling and referral services. Retirement benefits include the GE Aerospace Retirement Savings Plan, a 401(k) savings plan with company matching contributions and company retirement contributions, as well as access to Fidelity resources and planning consultants. Other benefits include tuition assistance, adoption assistance, paid parental leave, disability insurance, life insurance, and paid time-off for vacation or illness.
GE Aerospace (General Electric Company or the Company) and its affiliates each sponsor certain employee benefit plans or programs (i.e., is a "Sponsor"). Each Sponsor reserves the right to terminate, amend, suspend, replace or modify its benefit plans and programs at any time and for any reason, in its sole discretion. No individual has a vested right to any benefit under a Sponsor's welfare benefit plan or program. This document does not create a contract of employment with any individual.
The base pay range for this position is 100,000.00 - 115,000.00. The specific pay offered may be influenced by a variety of factors, including the candidate's experience, education, and skill set. This position is also eligible for an annual discretionary bonus based on a percentage of your base salary/ commission based on the plan. This posting is expected to close on **November 30th, 2025.**
_This role requires access to U.S. export-controlled information. Therefore, employment will be contingent upon the ability to prove that you meet the status of a U.S. Person as one of the following: U.S. lawful permanent resident, U.S. Citizen, have been granted asylee or refugee status (i.e., a protected individual under the Immigration and Naturalization Act, 8 U.S.C. 1324b(a)(3))._
**Additional Information**
GE Aerospace offers a great work environment, professional development, challenging careers, and competitive compensation. GE Aerospace is an Equal Opportunity Employer (****************************************************************************************** . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
GE Aerospace will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
**Relocation Assistance Provided:** No
\#LI-Remote - This is a remote position
GE Aerospace is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.