Quality Systems & Investigations Specialist
Quality technician job in Boston, MA
Title: Quality Systems & Investigations Specialist
Employment Type: Contract
Status: Accepting Candidates
About the role
This position plays a key role in supporting daily manufacturing activities by resolving operational issues and driving high-quality investigations. The role ensures process reliability through strong technical oversight and collaboration with critical operations teams.
Key Responsibilities
• Lead real-time floor support, triaging deviations and initiating root cause investigations.
• Produce thorough, compliant quality documentation for deviations, CAPAs, and impact assessments.
• Partner with manufacturing, QC, facilities, and materials teams to define corrective and preventive actions.
• Apply structured scientific thinking to evaluate data and support operational decisions.
• Contribute to process improvement by identifying trends and proposing optimized workflows.
Qualifications
• 6+ years experience in pharma/biotech manufacturing environments.
• Proven background in investigations, RCA, QC analytics, and GxP documentation.
• Skilled in cross-functional coordination and rapid issue assessment.
• Strong analytical mindset with the ability to interpret complex data sets.
• Experience supporting manufacturing operations in fast-paced, regulated environments.
Compensation (MA Pay Transparency):
• Estimated hourly range: $50-$58/hr (W-2).
• Final rate within this range will be based on skills, experience, and interview results.
Quality System Specialist / Senior Quality System Specialist
Quality technician 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 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
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Third Party Management Specialist/Quality Assurance Associate II (Scientific)
Quality technician job in Framingham, MA
Immediate need for a talented Third Party Management Specialist/Quality Assurance Associate II (Scientific). This is a 06+ Months Contract opportunity with long-term potential and is located in Framingham, MA (Onsite). Please review the job description below and contact me ASAP if you are interested.
Job ID:25-95197
Pay Range: $35 - $48/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
Key Responsibilities:
Role will work with some of the smaller vendors, will reach out to and worker.
This is not a post market compliance role, this is on material compliance role - single use system, defects of materials, they'll reach out to supplier to conduct investigations.
Key Requirements and Technology Experience:
Skills-Material Compliance, Quality Operations, quality agreement, Change Notification, FDA.
Must have a Bachelor's degree + 6 years of applicable experience.
Manager is open to all levels of experience
Previous experience with Veeva, quality agreements, supplier compliance, and supplier change notifications preferred.
Our client is a leading Pharmaceutical Industry and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.
Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
By applying to our jobs you agree to receive calls, AI-generated calls, text messages, or emails from Pyramid Consulting, Inc. and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here.
Quality Assurance Technician
Quality technician job in Westborough, MA
Our client is a global leader in e-commerce and cloud technology, recognized for innovation, customer obsession, and large-scale operational excellence. Based out of Westborough Massachusetts they are looking to hire a Quality Assurance Tech 1 on a Contract basis.
Contract Duration: 6 Month Contract (Potential for extension)
Required Skills & Experience
Read and understand electrical schematics
Ability to fabricate fixturing and perform board re-works, based on schematics
Board-level soldering experience
Experience with cable assembly and bring up
AS or BS in Electrical Engineering or equivalent industry experience experience testing hardware
Experience using standard electrical test/laboratory equipment
Oscilloscopes
Data acquisition devices
Digital multi-meters
Signal generators
Understand and execute documented test procedures
collect test data, document test artifacts and conditions
Troubleshoot electronic devices under test
Clear written and verbal communication for Test Engineers and external stakeholders
Proficiency working in a Linux/Unix environment, and executing simple scripts is a plus
Daily Responsibilities
Working with other Test Engineers, Hardware and Software developers regarding tools and techniques required for testing.
Maintain fixture uptime of existing fixtures
Troubleshoot electrical and control issues
Develop test subsystems and documentation
Execute tests and acquire test data
You will receive the following benefits:
Medical Insurance - Four medical plans to choose from for you and your family
Dental & Orthodontia Benefits
Vision Benefits
Health Savings Account (HSA)
Health and Dependent Care Flexible Spending Accounts
Voluntary Life Insurance, Long-Term & Short-Term Disability Insurance
Hospital Indemnity Insurance
401(k) including match with pre and post-tax options
Paid Sick Time Leave
Legal and Identity Protection Plans
Pre-tax Commuter Benefit
529 College Saver Plan
Motion Recruitment Partners (MRP) is an Equal Opportunity Employer. All applicants must be currently authorized to work on a full-time basis in the country for which they are applying, and no sponsorship is currently available. Employment is subject to the successful completion of a pre-employment screening. Accommodation will be provided in all parts of the hiring process as required under MRP's Employment Accommodation policy. Applicants need to make their needs known in advance.
Quality Engineer (Edifecs Project)
Quality technician job in Boston, MA
🚀 Contract Opportunity - Quality Engineer (Edifecs Project)
📍 Remote (U.S.-based only) | 💼 7-Month Contract | 💰 W2 Only
We're looking for experienced Quality Engineers to join a remote Edifecs project within the U.S. healthcare domain. This is a 7-month W2 contract opportunity with a leading healthcare technology team.
Key Responsibilities
Review business requirements and data mappings related to the HealthRules Payor ecosystem.
Perform manual testing, create and execute test cases, and document results.
Design or contribute to comprehensive testing plans.
Conduct SQL-based validation and data analysis.
Collaborate with technical and business teams to ensure data accuracy and functional integrity.
(Optional) Contribute to testing automation or agentic testing initiatives.
Required Skills & Experience
Strong background in U.S. Healthcare systems and processes.
Hands-on experience with HealthRules Payor and HealthRules Data Warehouse.
Proficiency in SQL for validation and data testing.
Demonstrated experience creating and executing manual test cases.
Excellent attention to detail, documentation, and communication skills.
Must be authorized to work in the U.S. (W2 only) and reside within the United States.
Nice to Have
Familiarity with Edifecs integration and testing frameworks.
Exposure to automation or agentic testing tools.
📩 Interested? Apply today to join a dynamic remote team working on a transformative U.S. healthcare project.
Quality Control Technician
Quality technician job in Rochester, MA
Location: Rochester MA (100% On-site), 1st shift only 6:30A-3:30P M-F, salary range $72K-$82K, full-time role:
health insurance with an HRA, dental, vision, LTD, and a 401(k) retirement plan with an employer match. 3 weeks PTO, 1 week sick. Generous relocation package offered. Qualified candidates are encouraged to apply.
Large precast concrete supplier in Massachusetts and New Hampshire, providing high-quality products for over 70 years. Their extensive product range includes septic tanks, manholes, drainage structures, bulkheads, curbing, residential steps, and retaining wall systems, all crafted to precise specifications. They cater to engineers, contractors, and homeowners, emphasizing superior performance and exceptional customer service.
The Quality Control Technician (“QC Technician”) will work within the production plant and is ultimately responsible for product testing. The QC Tech will assist in the execution of quality control processes, procedures and protocol associated with the production of pre and post concrete pours.
Responsibility
Responsible for ACI concrete field tests
Responsible for quality control inspections in manufacturing plant
Inspect forms before pouring (Pre-Pour).
Inspect product after removed from forms (Post-Pour)
Notifies Production Supervisor if deficiencies are found.
Perform and/or schedule repairs on products as needed.
Housekeeping - maintain a clean work area. Including cleanliness within breakroom, restroom, and general facility areas.
Expected to maintain knowledge of precast plant techniques and procedures.
May assist with precast production operation as needed.
Characteristics
Always committed to safety. Maintain a safe work area. Follow safe work practices as outlined in the Safety Program.
Always committed to quality. Follow and implement quality control measures.
Excellent attendance.
Reliable means of transportation to and from work.
Ability to learn, organize and prioritize work and handle multiple tasks.
Outstanding attitude, honesty, and ethic at all times.
Expected to use sound judgment, diplomacy, and discretion.
Work independently or cooperatively with others.
Self-drive in carrying out the functions of the job.
Requirements:
ACI Concrete Field-Testing Grade 1 Certified (preferred)
NPCA PQS Training
Must be at least 18 years of age per federal guidelines.
Good communication skills, both verbal and written to all levels of staff
Ability to remain focused in busy environment.
Computers and tablets skills in order to perform tasks.
Ability to read blueprints and sketches.
NPD Quality Engineer
Quality technician job in Plymouth, MA
Must Have Technical/Functional Skills
• Knowledge on Quality Management and its tools & techniques
• Knowledge about GMP (Good Manufacturing Practices), FDA, ISO 13485 and compliance regulations
• Knowledge on Medical Device Regulatory Standards, MDD and MDR
• Knowledge on NC, CAPA, Root Cause Analysis and Audit processes
• Knowledge on Validation process, writing protocols/ reports
• Very good understanding/ experience in writing procedures, product specs and work instructions
• Knowledge in Statistics, Risk Management and Design control
• Must possess good communication skills (verbal and written), familiar with project management methodology, problem solving, and presentation skills
• Experience in creating FMEAs & Writing reports
• Experience in PMS (Post Market Surveillance)
• Experience in PLM Tool (Windchill)
• Good understanding of Design, Drawing and GD&T
• Excellent Interpersonal / communication skills, Organizational / planning and Project management skills preferred
• Personal computer skills, Windows: word processing, presentation, e-mail, web browsers & spreadsheet software
• Ability to work efficiently, meet timelines, and communicate status (generate trackers, send emails, etc.)
Roles & Responsibilities
• Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, the duties and responsibilities for this position are:
• Development and review of PDP (Product development Process) deliverables
• Review and approve R&D/ Engineering protocol/ reports
• Development of Risk management records (i.e. DFMEA/ PFMEA) in collaboration with SMEs
• Support and provide guidance on Validations and if required write Validation Protocols/ Reports
• Support/ Remediation of Validation/ Quality Documentation
• Support Root Cause Investigation and closure of NC and CAPA
• Review and approve the Change Orders (CR/ CN)
• Review and update the design/ process control documents like procedures/ work instructions/ product specs etc.
• Work with cross functional teams and internal teams to create deliverables
• Performs other duties assigned as needed
Salary Range: $90,000 $95,000 Year
TCS Employee Benefits Summary:
Discretionary Annual Incentive.
Comprehensive Medical Coverage: Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans.
Family Support: Maternal & Parental Leaves.
Insurance Options: Auto & Home Insurance, Identity Theft Protection.
Convenience & Professional Growth: Commuter Benefits & Certification & amp; Training Reimbursement.
Time Off: Vacation, Time Off, Sick Leave & Holidays.
Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing.
Failure Analysis Lab Technician III: 25-07287
Quality technician job in Westborough, MA
Primary Skills: Electrical Testing (Expert), Failure Analysis (Expert), Sample Preparation (Expert), Troubleshooting (Expert), Laboratory Management (Expert) Contract Type: W2 Duration: 6 Months with possible extension Pay Range: $50 - $55 per hour on W2
#LP
Job Summary:
We are seeking an experienced Quality Assurance Tech III to support our Hardware Failure Analysis team within Robotics. The successful candidate will be instrumental in conducting detailed failure analysis investigations by preparing and analyzing samples, troubleshooting, and closely collaborating with engineers on technical assessments. This role requires a hands-on approach, a keen eye for detail, and a solid understanding of laboratory best practices.
Key Responsibilities:
Perform advanced metallographic preparation techniques (cutting, mounting, polishing, etc.).
Conduct basic electrical testing and troubleshooting of PCBs and electronic components.
Execute basic soldering and desoldering techniques.
Carry out micro sectioning of PCBs and electronic packages.
Manage and maintain laboratory equipment, ensure calibration, control inventory, and uphold a clean and safe work environment.
Must-Have Skills:
Proficiency in sample preparation and analysis.
Strong troubleshooting and technical problem-solving skills.
Ability to conduct and interpret electrical tests on hardware components.
Industry Experience Required:
Prior experience in a research and/or industrial laboratory setting is essential. Familiarity with electronic components' failure analysis within the robotics or related sector is highly preferred.
This role is ideal for someone passionate about hardware failure analysis and looking for a challenging, yet rewarding opportunity to contribute to cutting-edge technology developments.
ABOUT AKRAYA
Akraya is an award-winning IT staffing firm consistently recognized for our commitment to excellence and a thriving work environment. Most recently, we were recognized Inc's Best Workplaces 2024 and Silicon Valley's Best Places to Work by the San Francisco Business Journal (2024) and Glassdoor's Best Places to Work (2023 & 2022)!
Industry Leaders in IT Staffing
As staffing solutions providers for Fortune 100 companies, Akraya's industry recognitions solidify our leadership position in the IT staffing space. We don't just connect you with great jobs, we connect you with a workplace that inspires!
Join Akraya Today!
Let us lead you to your dream career and experience the Akraya difference. Browse our open positions and join our team!
Quality Systems Engineer (Medical Devices Industry) @ Andover, MA
Quality technician job in Andover, MA
WHO WE ARE
Nextphase.ai is a Data Management solution provider focused on Data Operations services for enterprise data in the cloud. We are leading the innovation agenda with our clients by delivering a portfolio of services to help them improve data quality and manage data governance for their cloud data. NextPhase.ai data management services are tailored to achieve our client's business outcomes thus enabling our clients to focus on monetizing their data while we handle data operations. Nextphase.ai provides you with a dynamic and fun work environment and encourages you to use creative thinking to solve client challenges.
Position Overview:
We are seeking a dynamic, analytical thinking individual to join our Quality team, this is a contract position focusing on Quality Systems, CAPA, Complaint handling, Internal Audit, metric reporting and process improvement initiatives. The ideal candidate will possess a strong background in medical devices or IVD, with a proven track record in managing quality-related activities in a fast-paced dynamic environment. QMS experience is essential.
Responsibilities:
This position is responsible for, but not limited to, the following:
Supports the overall QMS processes for the organization. Responsible for activities required to ensure compliance of Quality Management Systems (QMS), specifically regarding CAPA, complaints and internal/external audits. Additional responsibilities include supporting other QMS functions such as NCMRs, Supplier Controls, Management Review, Risk Review, etc.
Execution and coordination of activities associated with CAPA program, including administration and record management, providing quality input to investigations, reporting, as well as metrics and trending
Support CAPA Owners in quality-related technical principles, including but not limited to Problem Solving tools and techniques (Root Cause Analysis, DOE, FMEA, etc.)
Investigate customer complaints, from intake through investigation and closure
Manages the Internal Audit program, including scheduling audits, ensuring timely response to findings, as well as metrics and trending
Development of Quality Metrics, and coordination of quality data collection and analyses for use in monthly metrics meetings and Management Reviews
Provide quality assurance support cross-functionally across the organization
Develop, implement, and manage Quality Control/Quality System process improvements.
Identify opportunities for improvement within the Quality System to ensure compliance and efficiency. Correct or improve gaps/opportunities in an independent fashion by writing and releasing new or revised Quality System documentation
Understand how and when to escalate quality issues to leadership team within the organization, presenting data and information necessary to draw conclusions and take action
Provide training and support to employees on quality processes and procedures
Support work on quality plans, quality processes
Minimum Qualifications:
Bachelor's Degree in Engineering, Biomedical Science, or other technical discipline preferred, with 3-6 years of relevant experience in medical device industry, including responsibility for Product Quality and/or Quality Systems
A working knowledge of Quality System Standards and regulations, including 21 CFR Part 820, ISO 13485, EU MDR
Preferred Qualifications:
Ability to multitask, handling multiple projects and changing priorities
Experience in the creation and documentation of procedures and processes
Must be results-driven and exhibit a sense of urgency
Proficiency with Microsoft Office - Word, Excel, PowerPoint and Access experience required
Ability to communicate ideas and information clearly, effectively, and frequently (both oral and written)
Ability to exercise independent judgment in methods, techniques, and evaluation criteria for obtaining results
Ability to act independently to determine methods and procedures
Problem-solving skills and the ability to resolve issues as they arise
Strong interpersonal skills, with the ability to assimilate with various cross-functional teams
Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship or employment visas currently.
NextPhase.ai is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
Quality Ctrl Tech - 2nd Shift
Quality technician job in Attleboro, MA
The primary result expected from the Quality Control Technician will be to assure product quality by preparing samples, conducting quality control inspection and testing of components, dispersions, and finished goods, determining adjustments for batches that do not conform to requirements, documenting inspections, and insuring calibration of testing equipment.
Essential Duties & Responsibilities:
* Perform testing of production batches, incoming raw materials, finished goods, and components to determine conformance to specifications.
* Judge as "fit for release" production batches, incoming raw materials, finished goods, and components that are in conformance to all specifications and visually acceptable.
* Determine and communicate batch adjustments for any batches that do not conform to requirements, utilizing batch history, adjustment guidelines, and consultation with the Senior QC Technician, Assistant Supervisor, or QC Manager.
* Perform validation testing during filling to insure integrity of finished goods, including labeling, packaging, and fill weights.
* Communicate current status of inspections to Senior Technicians, Assistant Supervisor, or QC Manager.
* Communicate issues with work instructions and procedures to Senior Technicians, Assistant Supervisor, or QC Manager.
* Document inspection results.
Required Experience:
* 1-3 years of production/manufacturing/quality control experience preferred but not required.
* High school diploma or equivalent, Associate's or Bachelor's degree a plus
* Some background in physical sciences and algebra
* Ability to accurately read and enter computer data through a variety of tests
* Proficiency in Excel, Word, and other MS Office applications
* Experience in SAP recommended but not required
Rust-Oleum is an equal opportunity employer. Employment selection and related decisions are made without regard to sex, race, age, disability, religion, national origin, color, or any other protected class.
Auto-ApplyQuality Technician I
Quality technician job in Putnam, CT
Quality Technician I Wage: $23.65 + $2.00 shift differential shift: 2nd Shift- 2:30pm-11:00 pm
From a small family business to a multi-billion dollar global company, Sonoco has been changing the face of products and packaging since 1899 - all while keeping the heart of “People Build Businesses” alive. Our talented people are at the core of our growth, constantly reinventing the Sonoco wheel with brilliant solutions every year. Today we are a world leader in global packaging solutions with diversified operations in over 34 countries. We're extremely proud of our portfolio of brands, our achievements in sustainability and industrialization and the groundbreaking work accomplished by our people.
While reporting to the Quality Manager as a Quality Technician you will be require to use problem-solving techniques in routine job activities and team settings, performs all responsibilities in a manner, which ensures the quality expectations of every customer, both internal and external, are met or exceeded.
Measures critical product/process variables, records or reports using appropriate tools and utilizes information to continuously improve. If unable to maintain processes within established limits or meet specifications, is fully authorized to stop the operation and seek assistance.
What you will be doing:
· Conduct required off-line testing for products.
·Ensure all customer feedbacks are completed on-time, root cause is identified and implemented.
·Assist in analyzing all customer feedbacks for trends and continuous improvement.
· Involved in corrective action and preventive action process.
·Assist in process capability studies as deemed necessary.
·Assist and/or train plant personnel in GIQ quality system.
· Assist in maintaining customer property.
·Assist in maintaining process for document control.
·Document COA's, COC's as required.
·Participates on customer visits.
·Defines quality concepts and quality processes, including statistical basics, etc.; applies quality tools; interprets information and data; applies team concepts.
·Where applicable, support the food safety team to organize its work, ensure relevant training and education of the food safety team members, ensure the food safety management system is established, implemented, maintained and updated, and report to the organization's top management on the effectiveness and suitability of the food safety management system
We'd like to hear from you if:
· Ability to push, pull, lift and/or carry up to 50 pounds on a frequent basis and up to 75 pounds on an occasional basis.
· Ability to frequently bend, stand, stoop and grasp.
· Ability to manipulate small parts on a consistent basis.
·Must know which measurement and test equipment (M&TE) tools are appropriate for various tasks and how to assess tool accuracy and precision; understands the concept of standards traceability for M&TE.
·Understands and applies basic inspection and testing techniques, including various types of sampling plans.
·Understands and applies various quality audit types and their components, tools, and techniques.
·Must be able to control nonconforming material.
·Performs miscellaneous job-related duties as assigned.
At Sonoco Products Company, we offer a comprehensive total rewards package, including competitive pay and benefits.
*Benefits listed below are for employees located in the U.S. Specific benefits and wellbeing programs may vary depending on your location (within the U.S. or global), or if you are a union employee.
Benefits
Medical, dental, and vision coverage for you and your dependents, including FSA and HSA options
401(k) retirement plan with company match
Wellbeing tools and resources to support holistic health, including an Employee Assistance Program with a variety of services
Paid time off and holidays to recreate, rejuvenate and care for the health of yourself and family
Variety of company paid and voluntary employee-paid insurance plans including life, personal accident, and disability insurance
Tuition reimbursement
We are an equal opportunity employer, and we strictly prohibit and do not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, national origin or ancestry, sex, pregnancy, sexual orientation, marital status, gender identity or expression, age, disability, genetic information, veteran status, or any legally protected characteristic.
Auto-ApplyPart-Time Quality Technician
Quality technician 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
Metrology Quality Technician
Quality technician job in Beverly, MA
We're hiring a Metrology Quality Technician to join our quality team. This role is hands-on with CMM programming, precision inspections, and GD&T, ensuring our products meet the highest standards. You'll support engineering, new product development, and quality investigations while working with cutting-edge inspection tools.
Key Responsibilities
Program and troubleshoot CMMs;perform precision inspections including FAIs.
Apply GD&T and ASME standards to ensure product compliance.
Use a variety of inspection tools (calipers, micrometers, vision systems, 3D scanning, etc.).
Partner with engineers and quality teams to improve inspection methods and support new product development.
Document inspection results and contribute to quality investigations.
Qualifications
Associate degree or higher in engineering, design, or manufacturing.
3+ years of experience in measurement, CMM programming, and GD&T.
6+ years in a manufacturing environment.
Strong knowledge of inspection tools and ASME Y14.5 (certification preferred).
Proficiency with Microsoft Office;strong communication and teamwork skills.
Why Join Us
Work with advanced inspection technology in a clean, collaborative environment.
Be part of a team dedicated to precision, quality, and continuous improvement.
Opportunities to grow your skills and contribute to impactful projects.
Operations Quality Technician
Quality technician job in Acton, MA
Title: Operations Quality Technician Shift: Friday - Sunday 6am - 6: 30pm Duration: 6 months with possible extension
As long as they work out, they should be converted to FTE after 90 days.
The Operations Quality Technician will be a critical contributor in a mission that truly represents a once-in-a-lifetime opportunity to join a company that is making significant investments in establishing US manufacturing, expanding internationally, and delivering a consistent cadence of product innovations to the market and investing in its people.
The successful candidate will be responsible for ensuring our manufacturing site produces and distributes products which meet or exceed all established quality standards and will be responsible for ensuring our processes and procedures are compliant with corporate policies and federal law. The individual will be trained in performing Incoming, In-process inspections in the cleanroom, or assessing the final product's efficacy prior to market release. In addition to those activities, this position may also be required to support production operations, metrology, microbiology, or other manufacturing functions as business needs arise. This position requires a strong attention to detail, problem solving skills, and willingness to work in a fast-paced manufacturing environment.
Responsibilities
Inspect and record results of work on Incoming raw material, In-process, or Lot Qualification at various stages of the production process, distribution process to determine and maintain the quality and reliability of our product.
Assess and complete inspection reports and records including the entry of data into various electronic systems. (For example -Word, Excel, SAP, Electronic DHR systems, Oracle Agile, and others).
Generate, review, and maintain quality records in support of the Quality System. (For example -device history records and training records)
Ensure the equipment calibration status is within the timeframe of use.
Assist the Quality Manager in notified body and regulatory authority audits and inspections.
Works from specifications, work plans, procedures, and general instructions from either Quality Engineers, Quality Supervisor, or the Quality Manager.
Required to maintain and enforce cGMPs.
Safely follow standard operating procedures including but not limited to quality standards, material handling, and record keeping. Must follow all Good Manufacturing Practices (GMPs), Good Documentation Practices (GDPs), and Good Laboratory Practices (GLPs).
Notifies Quality or Operations Leadership of any discrepancies to ensure quality standards and safety of operations are maintained at all times.
Maintain a clean work environment suitable for medical device manufacturing and cleanroom production.
Performs other duties as required
Required Skills and Competencies:
Excels at the organization and maintenance records accurately.
Self-starter capable of dealing with a variety of tasks in a fast paced, multi-tasking environment.
Must be proficient in English language to be able to read documentation, communicate, and write.
Mathematics -Basic mathematics skills (adding, subtracting, multiplying, dividing)
Autonomy - Capable of working independently with minimal instruction from their supervisor.
Education and Experience
Minimum Requirements:
High School diploma
Preferred Competencies:
Familiarity with measurement instrumentation such as micrometers, calipers, tensile testers, video microscopes, and optical gauging products preferred.
Experience working in a lab setting environment in the medical device industry.
The ability to use stereoscopes and varying microscope setups.
Physical Requirements:
Required to stand for up to 75% of working time per shift, with walking at least 50% of working time per shift.
Required to reach above shoulder frequently and below waist occasionally.
Required to push and pull.
Ability to lift up to 20lbs occasionally, 5-20lbs frequently.
Vision capability to inspect small parts/components/labeling (Corrective lenses allowed)
Quality Technician | Titleist
Quality technician job in Lakeville, MA
Where Performance Meets Purpose
Join a team that values excellence and innovation, at a company known for its iconic golf brands. At Acushnet Company, your background and experience contribute to creating the best products for dedicated golfers worldwide. Here, your performance has purpose.
Where Performance Meets Purpose
Join a team that values excellence and innovation, at a company known for its iconic golf brands. At Acushnet Company, your background and experience contribute to creating the best products for dedicated golfers worldwide. Here, your performance has purpose.
What You Will Be Doing
Join our team at Titleist Custom Gear, where precision and craftsmanship define everything, we do. As a Quality Technician, you'll play a vital role in ensuring the highest standards of product and process quality for our custom gear operations. In this position, you will conduct first-piece and in-process inspections, oversee inventory reconciliation, and maintain detailed standards manuals to guarantee accuracy and consistency. You'll act as a key resource for quality assurance-leading audits, resolving issues through problem-solving techniques, and supporting both in-house teams and external partners. Beyond inspections, you'll contribute to continuous improvement initiatives, deliver impactful training programs, and refine best practices to uphold our commitment to excellence. If you're detail-oriented, passionate about quality, and thrive in a collaborative environment, we invite you to help us elevate the Titleist brand experience.
What You Bring
Education
High School Diploma or equivalent required
Associate degree preferred
Experience
Minimum 2 years in quality testing/inspection role required
Knowledge of textiles, sewing, or embroidery preferred
Physical Requirements/Environmental Factors
Ability to work with minimal supervision and flexible hours
Some overtime and Saturday work may be required
Specialized Knowledge and Skills
Strong analytical and organizational skills; ability to manage multiple priorities
Excellent written and verbal communication; strong interpersonal skills
Proven ability to build strong internal and external relationships
Strong problem-solving skills; ability to work independently
Attention to detail and organizational skills required
Strong Excel skills; experience with Microsoft Office
Working proficiency in English (written and spoken) to quickly learn technical aspects
Our Commitment to You
At Acushnet Company, we are committed to helping our associates thrive both personally and professionally. From the start, you and your family, including domestic partners, will benefit from a comprehensive suite of health and well-being programs. Enjoy the advantages of paid time off, an onsite fitness center, acupuncture, physical therapy, wellness coaches, and more.
Our financial benefits are designed to secure your future, offering a 401k with company match, health savings accounts, and flexible spending accounts.
Additionally, you'll enjoy perks like pet insurance, legal planning, education assistance, and exclusive access to our Associate Store. At Acushnet Company, your performance has purpose, and we're here to support you every step of the way.
EEO and Additional Statements
Acushnet Company is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with a disability. EEO Employer/Veteran/Disabled.
Acushnet Company respects the intellectual property and confidential information of third parties. Our policy is that no employee or applicant shall disclose confidential information of a third party to Acushnet Company. Accordingly, please do not include any confidential information of a current or previous employer on your resume or any other materials you provide to us.
Acushnet Company participates is E-Verify. Please click here for more details.
Global Candidate Privacy Notice
Our Commitment to You
At Acushnet Company, we are committed to helping our associates thrive both personally and professionally. From the start, you and your family, including domestic partners, will benefit from a comprehensive suite of health and well-being programs. Enjoy the advantages of paid time off, an onsite fitness center, acupuncture, physical therapy, wellness coaches, and more.
Our financial benefits are designed to secure your future, offering a 401k with company match, health savings accounts, and flexible spending accounts.
Additionally, you'll enjoy perks like pet insurance, legal planning, education assistance, and exclusive access to our Associate Store. At Acushnet Company, your performance has purpose, and we're here to support you every step of the way.
Pay Range: $48,503.00-$59,963.00
Ready to Make an Impact?
Join us at Acushnet Company and be part of a team that values excellence and innovation.
EEO and Additional Statements
Acushnet Company is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with a disability. EEO Employer/Veteran/Disabled.
Acushnet Company respects the intellectual property and confidential information of third parties. Our policy is that no employee or applicant shall disclose confidential information of a third party to Acushnet Company. Accordingly, please do not include any confidential information of a current or previous employer on your resume or any other materials you provide to us.
Acushnet Company participates is E-Verify. Please click here for more details.
Global Candidate Privacy Notice
Auto-ApplyTechnician, Quality
Quality technician job in Wilmington, MA
Quality Technician
Onsite, Hybrid or Fully Remote
Onsite
Status
Full-Time
Reports To
Quality Manager
FLSA Status
Non-Exempt/Hourly
Management Position
No
Overview
Kovalus Separation Solutions (KSS) is looking for Chemical Operators to join their team. We provide on the job training and a great team atmosphere. The right person must be open to learning, taking constructive feedback, and have the drive to be successful. In this role you will follow detailed chemical mix instructions, processes, and procedures to create membrane solution.
At Kovalus Separation Solutions (KSS), we are dedicated to transforming the landscape of separations by leveraging synergistic technologies such as membrane filtration, ion exchange, evaporation, drying, and more. Our solutions help customers in the food and beverage, dairy, life science, and industrial markets produce high-quality products through concentration and purification, remove contaminants and recycle valuable process chemicals, achieve high-purity water, and treat wastewater for suitable discharge or even reuse to increase sustainability in their operations. Our success is rooted in the collaborative teamwork of our exceptional employees across the world. As KSS continues to expand, we are always seeking outstanding professionals in all aspects of our business. Come join our team today and help us deliver Separation Technologies for a Better Future™.
This role is not available for Sponorship now or in the future.
Responsibilities
Typical activities include:
Ownership of the Customer Returns and Investigations Laboratory, RMA (Returned Material) room and Inspection room. Responsible for their safety, cleanliness, organization
Support Customer Care Program by owning Customer Returns and Investigations work. This includes organizing Investigation meetings, managing material that has been returned from customers, conducting some simple hands-on work and writing draft reports to summarize the investigations
In charge of the facilities calibrations in the campus. Including organizing equipment, scheduling with external vendor. Coordinating with internal Production and Maintenance and maintaining calibrations records.
Conduct First Article Inspections and Receiving Inspections, and issue internal reports and identify Nonconforming Materials.
Participate Internal Audits and occasional Supplier Audits
Support External Customer audits as needed
Review test data as compared to specifications to determine if product is compliant and able to ship. Sign certificate of quality.
Other tasks related to the Kovalus Quality management, that may be deemed necessary
REQUIRED SKILLS AND EXPERIENCE:
Bachelors degree in Chemical Engineering or related Science disciplines
Microsoft Office at a basic level (Word, Excel, PowerPoint);
Able to lift up to 30 lbs. Job will require the person to, bend, reach, lift, kneel, and be on their feet for a couple of hours at a time.
Preferred skills that will put you ahead:
1 + years' experience working in a Manufacturing environment with exposure to Quality management;
Basic Knowledge of ISO 9001:2015 and ISO audits
Basic Knowledge of ERP systems
Good organizational skills, self-driven;
Able to prioritize and organize daily tasks
Excellent people skills and ability to communicate clearly verbally and through written communication;
Good organizational skills, self-driven;
Able to prioritize and organize daily tasks.
Physical Requirements:
Must be able to ascend and descend ladders, stairs, and in proximity to loud equipment.
Must be able to lift and carry or otherwise move up to 50 pounds occasionally.
Must be able to see and respond to at-risk situations.
Must be able to wear personal protective gear when in industrial locations.
Must be able sit for longer periods of time as well as move about throughout the office and production, / laboratory environment.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Kovalus offers a comprehensive package that includes: Medical (4 plan options), Dental (2 plan options) and Vision insurances; 401K (match & fixed company contribution); health savings and flexible spending accounts; company provided basic life insurance policy with the option of selecting additional voluntary life insurance for self, spouse or dependents; disability insurances (short-term policy is company paid & long-term is split between company and employee); voluntary insurance plans for accident, critical illness and hospital indemnity; business and personal travel insurance; 10 paid holidays; vacation time; sick time; employee assistance program; educational assistance program; referral bonus; bereavement leave. All benefits are subject to applicable plan and program terms (including eligibility terms) and may be subject to change.
Compensation-$19.57-$24.38
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Career Roadmap:
The next opportunity from this position is: Quality Technician II
Auto-ApplyFSQ Product Quality Tech
Quality technician job in Fall River, MA
Bringing
our
love
of
food
to
families
for
five
generations!
Blount
Fine
Foods
is
a
family-owned
and
operated
manufacturer,
marketer,
and
developer
of
premium
fresh
prepared
foods.
We
are
an
engaging
team,
bringing
restaurant-quality
products
to
America
including
single-serve
grab-n-go
fresh soups, mac & cheese, and entrées in grocery stores across the country, as well as for hot bars and restaurants. Help us create the finest food experiences including those with specialty certifications that include organic, gluten-free, and low sodium, among others. Join a proven team for growth, success, and a satisfying career!330pm - 12amEssential Duties and Responsibilities include the following. Other responsibilities w/similar skill and work conditions as assigned.· Conduct quality audits and influence the proper execution of culinary and cook methods so that product will meet desired quality levels. If necessary, use your culinary knowledge and good judgement to adjust inline to get product within specification.· Aids and Supports facility teams on investigating, analyzing, containing, and correcting quality issues related to customer complaints.· Serve as a resource/ coach for established quality standards and procedures, culinary training and technical support to reduce variability in each process.· Be present and integrated into production activities on the process floor.· Provide follow up monitoring, documenting and feedback of completed initiative controls.· Assure all organoleptic qualities and process standards are appropriate and consistently met.· Monitor and carry-out various batch control tests and product sampling to ensure process is in control.· Maintain, create, and communicate quality control reporting data.· Candidate must be able to interact in a dynamic team environment while displaying tact and diplomacy with peers and management alike in order to achieve goals.· Candidate must be reliable and flexible in order to meet seasonality demands of the business.· Passion for food, team player, influencer, good communicator and has high quality standards.Responsibilities for Food Safety Responsible for completing required paperwork accurately and honestly, where applicable.§ Responsible for completing required paperwork accurately and honestly as applicable.§ Must adhere to all corporate GMPs (Good Manufacturing Practices), established SOPs (Standard Operating Procedures) and all Food and Employee Safety policies.§ Must adhere to all Allergen control programs and procedures as applicable.§ Responsible for reporting suspicious packages, activities and individuals.§ If monitoring CCPs (Critical Control Points), must be trained in HACCP (Hazard Analysis Critical Control Point) and adhere to approved HACCP plan(s).Education and/or Experience· Associate degree (A. S.) from college or university. Culinary and process acumen. Culinary experience in a manufacturing environment preferred. Bachelor's Degree in a related discipline of Food Science, Statisticsor a Culinary field and 2+ years manufacturing experience preferably in a food environment, or equivalent combination of education and work experience.· Quality certification/training/experience preferred.Competencies: “An area of expertise that is fundamental to a particular job or function”In order to perform this position properly, each candidate must demonstrate the following core competencies (not all inclusive).§ Business Knowledgeo Effectively utilizes available tools to maximize contributiono Manages Resources effectivelyo Understands relationships of resources, process, and profito Ability to project future state, and the ability to prepare and deliver one's division to its optimum performance§ Interpersonal Skillso Builds relationships at all levelso Manages conflict effectivelyo Practices early intervention; resolves issues earlyo Communicates effectively; has a point of viewo Inspires trust and Teamworko Is a Motivator§ Judgmento Analyzes problems effectivelyo Demonstrates sound and ethical decision-making, even under pressureo Patient; challenges appropriatelyo Open to ideas of otherso Consistent§ Leadershipo Persuasive in getting others to consider his/her or companies point of viewo Inspires trust; viewpoint actively sought by otherso Fosters collaborationo Overcomes objections with logic and effective communication skillso Able to deliver message of “Culture change”; in a positive, constructive and effective mannero Is a Leader, and is viewed as one Language Skills· Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization.
Auto-ApplyQuality Technician
Quality technician job in Hopkinton, MA
Job Title Quality Technician About Us Revvity is a developer and provider of end-to-end solutions designed to help scientists, researchers, and clinicians solve the world's greatest health challenges. We pair the enthusiasm of an industry disruptor with the experience of a longtime leader. Our team of 11,000+ colleagues from around the globe are vital to our success and the reason we're able to push boundaries in pursuit of better human health.
Find your future at Revvity
Job Summary:
Quality Control Technician plays a vital role in maintaining product excellence by performing comprehensive inspection activities to support production operations. This position reports directly to the Quality Manager and ensures adherence to our rigorous quality standards.
Key Responsibilities:
* Conduct thorough product inspections according to Standard Operating Procedures (SOPs) to verify compliance with design specifications
* Perform incoming material inspections to ensure conformity with engineering drawings and requirements
* Generate Non-Conforming Material Reports (NCMRs) for products or materials that fail to meet specifications
* Facilitate Material Review Board (MRB) meetings to ensure timely disposition of non-conforming products or materials
* Create, maintain, and organize inspection records and retain samples according to quality protocols
* Identify and escalate quality issues to appropriate personnel to ensure prompt resolution
* Review and redline SOPs to align with standard work practices and continuous improvement initiatives
* Proactively identify and recommend process improvements through critical thinking and problem-solving
* Manage Quality Control inventory using Kanban system principles
* Verify test equipment and tools are properly calibrated according to established calibration programs
* Perform additional quality-related activities as assigned by management
The duties listed in this job description are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position.
Basic Qualifications:
* High School diploma or GED
* 1-2+ years of Quality Control experience in a regulated manufacturing industry
Preferred Qualifications:
* Associate degree in relevant field
* Experience with SAP or similar ERP systems
* Knowledge of ISO 9001:2015 QMS
* Experience with continuous improvement methodologies
* Proficiency with basic inspection tools (Calipers, Gauges, etc.)
* Strong problem-solving, critical thinking, and organizational skills
* Excellent written and verbal communication abilities
* Proficient in Microsoft Excel, Word, and Adobe Acrobat
* Ability to work collaboratively in a team environment
Physical Requirements & Expectations:
* Physical ability to lift and/or move up to 50lbs
Compensation Range:
The annual base salary range for this full-time position is $39.000-$49,000. This range reflects the minimum and maximum target for a new hire in this position. The base pay actually offered to the successful candidate will take into account internal equity, work location, and additional factors, including job-related skills, experience, and relevant education or training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.
Please note that base pay is only one part of our total compensation package and is determined within a range. This range allows for the successful candidate to have an opportunity to progress within the position and develop at our company. This base pay range does not take into account bonuses, equity, or other benefits which may be applicable and are dependent on the level and position offered.
What do we offer?
We provide competitive and comprehensive benefits to our employees. Below are some highlights of our benefits:
* Medical, Dental, and Vision Insurance Options
* Life and Disability Insurance
* Paid Time-Off
* Parental Benefits
* Compassionate Care Leave
* 401k with Company Match
* Employee Stock Purchase Plan
Learn more about Revvity's benefits by visiting our Bswift page. Log-In instructions are provided towards the bottom of the Bswift page.
* For benefit-eligible roles only. Part-time and temporary roles may not be eligible for all benefits listed. Please reach out to your recruiter for more information.
Revvity is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to any characteristic or status protected by applicable federal, state, and/or local laws. If you are an applicant with a disability that requires reasonable accommodation to complete any part of the application process or are limited in the ability-or unable to use-the online application system and need an alternative method for applying, you may contact ********************.
Easy ApplyQuality Systems Specialist
Quality technician job in Waltham, MA
About the job
Title: Quality Systems Specialist
Employment Type: Contract
Duration: 6+ months
Status: Accepting Candidates
About the Role
We're hiring a Quality Systems Specialist to support global Quality Systems operations for a leading biopharmaceutical manufacturing organization. This role is heavily focused on documentation, training, system governance, and validation support within a regulated GxP environment.
Key Responsibilities
Support Quality Systems operations to ensure compliance with SOPs and regulatory requirements (FDA, EMA, ICH)
Assist with governance of Quality System applications, including harmonization across sites
Gather and document system requirements through workshops and meetings with SMEs and process owners
Participate in user forums to collect, prioritize, and triage enhancement requests and system issues
Initiate, manage, and complete change controls, including required documentation
Maintain systems in a validated state (user access reviews, change management, deviation & CAPA support)
Support investigation, escalation, and resolution of system-related issues
Execute validation activities, including requirements gathering, validation planning, IQ/OQ support, test scripts, execution, discrepancy management, and validation reporting
Provide system administration, user onboarding, and training support
Qualifications
Experience supporting Quality Systems in a biopharma / pharmaceutical / life sciences environment
Strong background in documentation-heavy roles (SOPs, training materials, change controls)
Hands-on experience with change management, deviations, and CAPA
Familiarity with validated systems and GxP compliance
Exposure to QMS tools (e.g., TrackWise, Veeva, MasterControl) is strongly preferred
Strong communication skills and ability to work cross-functionally
Compensation (MA Pay Transparency)
Estimated hourly range: $40-$50/hr (W-2)
Final rate within the posted range will be based on skills, experience, and interview results
Quality Engineer, Analytical Development and Quality Control
Quality technician 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 Research Associate/Quality Engineer will be responsible for performing mechanical testing of materials and components using instruments such as Mecmesin, Instron, or equivalent force-measurement systems. This role will support tensile, compression, shear, puncture, and force displacement characterization to ensure product performance, robustness, and compliance with internal quality standards. In addition, the individual will contribute to method development, qualification activities, and routine QC release testing to support clinical and commercial manufacturing programs. This is a unique opportunity to be part of an emerging early-phase clinical company bringing innovative technology to the global market.
Key Responsibilities
Essential duties and responsibilities include the following. Other duties may be assigned.
Perform mechanical testing of materials, components, and finished MAP products using Mecmesin, Instron, or comparable systems, including tensile, compression, shear, puncture, and force displacement profiling.
Develop, optimize, and maintain mechanical test methods to support product characterization, comparability studies, and design verification/validation activities.
Execute routine QC mechanical release testing aligned with cGMP expectations and data integrity standards.
Troubleshoot mechanical testing issues, support instrumentation maintenance, and ensure proper calibration and documentation
Analyze mechanical test data, prepare technical reports, and document all activities in audit-ready laboratory records.
Collaborate cross-functionally with QC, Analytical Development, Process Development, Manufacturing, and Regulatory teams to enable program success.
Assist in broader QC testing efforts as needed, including support for analytical, functional, and stability assays.
Independently author method SOPs, analytical protocols, technical reports, and contribute to regulatory submissions.
Maintain rigorous laboratory documentation and complete, audit-ready analytical records.
Collaborate effectively with QC, Manufacturing, Process Development, and Regulatory teams to enable program success across phases.
Thrive in a fast-paced, cross-functional environment with excellent communication and organizational skills.
Qualifications
Bachelor's degree in Mechanical Engineering, Materials Science, Biomedical Engineering, or a related discipline; 1-3 years of relevant mechanical testing or QC experience, or a master's degree with applicable laboratory experience.
Hands-on experience with mechanical testing instruments such as Mecmesin, Instron, Texture Analyzer, or equivalent force-measurement systems.
Demonstrated proficiency in tensile, compression, shear, puncture, and force-displacement mechanical characterization.
Experience developing, optimizing, and/or qualifying mechanical test methods for materials, components, or finished products.
Familiarity with GMP, GLP, or ISO 17025 laboratory environments and strong understanding of data integrity (ALCOA+).
Ability to analyze mechanical test data, generate clear technical reports, and maintain accurate documentation.
Experience supporting QC release testing, method qualification, method transfer, or equipment qualification is a plus.
Strong organizational skills with the ability to manage multiple workflows and prioritize effectively in a fast-paced environment.
Excellent verbal and written communication skills and comfort working within interdisciplinary teams.
Commitment to collaborative work within interdisciplinary project teams.
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
******************
.