Director of Quality
Quality assurance manager job in Boston, MA
We're hiring a Director of Quality to lead QA/QC operations at our U.S.-based Contract Development & Manufacturing Organization (CDMO). This senior leader will ensure GMP compliance, oversee product release, and drive quality excellence across our clinical and commercial manufacturing programs.
What You'll Do
Lead QA, QC, and Quality Systems teams; build a strong quality culture
Oversee batch record review, product disposition, and client quality interactions
Maintain and improve GMP compliance, CAPA, deviations, change control, and training systems
Prepare the site for regulatory inspections (FDA, EMA) and client audits
Provide quality oversight for manufacturing, tech transfers, and validation activities
Drive continuous improvement, data integrity, and inspection readiness
What We're Looking For
Bachelor's in science or engineering (advanced degree a plus)
10+ years in GMP pharmaceutical manufacturing; 5+ years in Quality leadership
Strong command of FDA/EMA regulations, ICH guidelines, and CDMO environment
Proven success managing inspections, audits, and client relationships
Experience with aseptic, biologics, or high-potency APIs is a plus
Why Join Us?
Lead quality for a growing CDMO with diverse product portfolios
Influence site strategy and partner closely with clients and regulators
Competitive compensation, bonus, benefits, and development opportunities
Director of Quality Control
Quality assurance manager job in Cambridge, MA
Director, Quality Control (QC)
An innovative biotechnology company developing next-generation biologics and engineered fusion protein therapeutics focused on immune and autoimmune-driven diseases is seeking a Director of Quality Control. As multiple programs progress through IND-enabling studies and early clinical development, this leader will build and scale the QC function, ensure analytical excellence, and drive phase-appropriate GMP compliance across a growing modality portfolio.
Key Responsibilities:
QC Strategy & Leadership:
Build and lead a high-performing QC organization supporting a biologics and engineered fusion protein pipeline.
Develop QC strategy aligned with IND-enablement, early-phase manufacturing, tech transfer, and later-stage readiness.
Grow, mentor, and manage QC staff across analytical, microbiology, and sample management groups.
Establish scalable QC systems and processes that evolve with increasing program complexity.
Analytical & Method Lifecycle Ownership:
Oversee analytical testing for biologics and fusion proteins including potency, purity, structural characterization, binding assays, and cell-based functional assays.
Lead method development, qualification, transfer, and validation at internal labs and CDMOs while ensuring compliance with ICH Q2(R2), ICH Q6B, USP, and biologics-specific guidance.
Ensure robust specification setting, comparability strategy, and control strategy alignment as programs advance.
QC Operations & Laboratory Management:
Direct release and stability testing for drug substance, drug product, intermediates, and raw materials under global GMP standards.
Oversee QC laboratory capabilities, instrumentation strategy (HPLC/UPLC, CE, MS, ELISA, qPCR, cell-based platforms), and LIMS and data integrity systems.
Ensure efficient sample management, chain of custody, and accurate phase-appropriate documentation.
Quality Systems & Regulatory Readiness:
Lead QC investigations, OOS and OOT assessments, deviations, CAPAs, change controls, and stability commitments.
Support regulatory submissions including INDs, IMPDs, and BLAs through authoring and review of analytical and QC sections.
Represent QC in regulatory inspections and ensure readiness aligned with FDA, EMA, and ICH expectations for biologics and advanced modalities.
Cross-Functional Collaboration:
Partner with CMC, Process Development, MSAT, Regulatory, and External Manufacturing teams to support analytical control strategies.
Provide QC input for product lifecycle planning, risk assessments, fusion protein engineering updates, and comparability justifications.
Manage QC activities at CDMOs and external labs including vendor qualification and ongoing performance monitoring.
Qualifications
MS or PhD in Biochemistry, Molecular Biology, Immunology, Analytical Chemistry, or a related field.
10 to 15 years of QC experience in biologics or advanced modalities with at least 5 years in leadership roles.
Expertise in analytical technologies for recombinant biologics and engineered fusion proteins.
Experience supporting IND-enabling work, clinical material release, and method lifecycle management with CDMOs.
Strong understanding of global GMP, ICH Q2(R2), Q5E, Q6B, and biologics regulatory frameworks.
Proven capability in building QC teams, shaping lab infrastructure, and driving continuous improvement.
Excellent leadership, communication, and cross-functional collaboration skills.
Quality Systems & Investigations Specialist
Quality assurance manager 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 Assurance (QA) Specialist
Quality assurance manager job in Cambridge, MA
A recognized pharmaceutical company is actively seeking a new Quality Assurance (QA) Specialist to ensure data integrity and system compliance across clinical systems and cloud technologies.
Responsibilities:
Develop, document, and execute test plans, scenarios, and test cases for clinical trial applications and data workflows
Perform functional, regression, and integration testing to validate new features and ensure existing functionality remains intact
Utilize QTest for test management and documentation
Conduct defect management, including logging, tracking, and verifying fixes
Collaborate with development teams in an Agile environment to ensure timely and accurate testing
Identify and resolve data quality issues at the business level, ensuring compliance with regulatory standards
Work closely with stakeholders to validate requirements and deliver high-quality solutions
Qualifications:
5+ years of QA experience in the Clinical Trials / Pharma domain
Strong knowledge of AWS, Databricks, and clinical systems (CTMS, EDC, eTMF)
Proficiency in QTest for test case management
Experience with SQL and Athena for data validation
Experience with Python (ability to read and understand code)
Microsoft Excel (pivot tables, linked spreadsheets)
Familiarity with Jira for issue tracking and Agile workflows
Strong analytical and problem-solving skills with attention to detail
Desired Skills:
Solid understanding of Clinical Data standards (CDISC, SDTM)
Knowledge of GxP Compliance and Regulatory requirements
Food Safety and Quality Assurance
Quality assurance manager job in Leominster, MA
Masis Professional Group is recruiting for a Food Safety and Quality Assurance Manager on behalf of our client located in Leominster, MA. This is a direct hire opportunity offering a competitive hourly salary and benefits package.
FSQA Manager, or Food Safety and Quality Assurance Manager, is responsible for ensuring that food products meet all safety, quality, and regulatory standards. This involves developing and implementing food safety programs, conducting audits, overseeing compliance with regulations, and training staff on proper safety protocols.
Requirements of the Food Safety and Quality Assurance Manager:
Experience working with GFSI auditing - SQF preferred
SQF Practitioner
PCQI - FSMA training
HACCP Training
Proficient with Microsoft office suite
2-5 years' experience managing a team
Familiar with prerequisite programs - allergen, supplier management, sanitation, recall and traceability etc.
Able to lead and determine root cause analysis in a corrective and preventive action situation.
Able to review and respond to customer complaints.
Ability to identify and correct nonconformities in system processes, gmps, and employee practices.
Confidently communicate resource needs to upper management.
Implement, monitor, and provide training related to food safety plan, gmps and industry best practices.
Desirable Requirements of the Food Safety and Quality Assurance Manager:
Bilingual with Spanish
Food Defense Training
Internal Auditing training
Experience working with food contact packaging
Experience working with regulatory agencies
Experience reviewing and formatting NLEA labeling, Ingredient statements, allergen statements and claims to meet CFR regulations.
Quality System Specialist / Senior Quality System Specialist
Quality assurance manager 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
******************
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R&D Strategy Manager
Quality assurance manager job in Cambridge, MA
Who We Are
Strand Research is a biotechnology startup dedicated to developing and optimizing novel molecules for haircare applications to be launched in a new brand. Positioned at the crossroads of science and beauty, we are committed to innovation driven by rigorous data and relentless pursuit of efficacy, creating solutions that will set new industry standards and redefine what is possible in hair care. Our lab is based in Kendall Square and we have secured substantial funding, providing us with several years of runway to bring groundbreaking ingredients to market.
We have made major progress on the science side, and are now looking for a R&D strategy manager to help turn that innovation into real, high-impact products. The ideal candidate is a results-driven, high octane, resourceful individual who thrives in a fast-paced, high intensity environment with a passion for science and consumer goods.
You will partner directly with scientists and leadership to shape program strategy, define what “good” looks like, and help identify the most promising directions across our portfolio. You'll translate high-level scientific concepts into focused, achievable plans, ensuring that every project has clarity and momentum.
We're looking for a sharp generalist with both strategic depth and executional grit, someone who can move fast, wear multiple hats, and help shape our research outcomes.
What You Will Do
Work with scientific leads to define hypotheses, sharpen project goals, and prioritize the programs with the highest potential impact
Build clear, aggressive plans that translate research into focused milestones and decision points
Help shape and execute our IP strategy, pulling in the technical narratives and experimental data to strengthen and accelerate our filings
Deliver strategic updates that give leadership visibility into progress, roadblocks, and opportunities across the R&D portfolio
Build and lead relationships with vendors, CROs, academic partners, and other external partners to accelerate progress to market
Do whatever it takes to move our best leads through development and into market-ready products
Who You Are
3-5+ years of full-time experience in consulting, finance, high-growth start-up, or similar high-intensity role
Scientific degree or deep, self-driven interest in science
A self-starter with a desire to win
Disciplined and organized, with the ability to create structure for ambiguous problems
Strong interpersonal skills with ability to manage many different stakeholders
A “doer” and a thinker who is willing to get hands dirty in execution while maintaining a strategic mindset
Strong analytical skills with a bias for insights and results
Passionate about the intersection of science and the consumer
Additional Information
This position is hiring for an immediate start, with some flexibility for the right candidate
This position is in-office in Cambridge, MA
The salary for this position is commensurate with experience
Interested? Reach out to learn more and apply at ************************
Quality Systems Engineer (Medical Devices Industry) @ Andover, MA
Quality assurance manager 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.
POS Quality Engineer
Quality assurance manager 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 (Edifecs Project)
Quality assurance manager 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 Engineer
Quality assurance manager job in Portsmouth, NH
Alexander Technology Group is looking for a Quality Engineer for a client based in the Portsmouth, NH area.
This is full-time (perm)
On-site in Portsmouth, NH
Key Responsibilities:
Develop and maintain quality systems for combination products.
Ensure compliance with FDA, ISO 13485, cGMP, and other standards.
Lead risk assessments, root cause analyses, and corrective actions.
Oversee testing, validation, and documentation processes.
Collaborate with R&D, manufacturing, and regulatory teams.
Conduct training on QA practices and support continuous improvement.
Perform inspections and product testing to ensure quality standards.
Qualifications:
Bachelor's in Engineering, Life Sciences, or related field.
Strong knowledge of regulatory requirements and quality tools (e.g., Six Sigma, CAPA, FMEA).
Excellent problem-solving and communication skills.
Able to work independently in a small team environment.
Preferred:
Experience with design control, eQMS, and statistical tools.
ASQ CQE certification.
3+ years in QA/QE roles with combination products.
If interested, please send resume to ************************
Quality Manager
Quality assurance manager job in Littleton, MA
Job Posting Start Date 11-03-2025 Job Posting End Date 01-31-2026
At JetCool, a Flex company, we're at the forefront of liquid cooling innovation, delivering advanced solutions that empower our partners in AI and high-performance computing. United by a shared purpose, our teams are pushing the limits of what's possible and tackling complex challenges.
A career at JetCool offers the opportunity to make a real impact by helping build smarter, more sustainable data centers. Together, we're not just advancing technology - we're redefining cooling standards to create a more sustainable tomorrow.
Job Summary
JETCOOL Technologies is seeking an experienced Quality Manager in Littleton, MA to provide the analytics and guidance to effectively manage product and process quality for all JetCool products. Strong preference will be given to those who have designed and implemented total QMS systems in a start-up environment.
JETCOOL Technologies is a fast-moving technology company spun out of MIT and now a member of the Flex family. Our technology provides game-changing cooling solutions for aerospace, electric vehicles, and data centers. Join us to be part of one of today's fastest growing industries, while having a positive impact on society sustainability through innovative technologies.
What a Typical Day Looks Like:
Develops, implements, and coordinates product assurance programs to prevent and eliminate defects in existing products and future new products
Leads the creation and implementation of a comprehensive QMS system that identifies quality metrics and trends across the entire supply chain via customer field data leading to proactive management decision making
Work with external suppliers, domestically and internationally to validate in-factory quality management tools, controls and reporting mechanisms. Integrate supplier quality data into JetCool quality control methods assuring timely and collaborative management of on-going product quality.
Perform regularly scheduled on-site quality audits at key suppliers, assuring compliance with JetCool quality standards.
Participates in, and work with Design Engineering during NPI development programs ensuring Design for Quality considerations are embedded in and validated the NPI release process
Evaluates and leads the discovery of field return quality issues, drives root cause investigations, and recommends corrective actions
Establish statistical process control measurement methods to gather product and process quality performance
Acts as the point of contact for all internal and external quality issues across the supply chain (suppliers, raw stock, WIP, finished goods, warehouses, field deployments)
The Experience We're Looking to Add to Our Team:
4-year college degree, masters preferred
Minimum of 7-10 years relevant industry experience
Experience working with fluid-mechanical systems consisting of fluids and pumps is preferred.
Demonstrated experience building QMS management systems in partnership with global suppliers.
Experience working with PLM and ERP systems.
Experience working with Customers as a prime point of contact for fielded quality issues.
Experience working with, integrating and converting product and process quality data into actionable information.
Experience working with regulatory bodies (e.g. Nemko, UL, TUV, CSA) hosting factory audits and ensuring in factory controls are in place and up to date.
Ability to travel to domestic and international suppliers, 10%-20%
What you'll receive for the great work you provide:
Full range of medical, dental, and vision plans
Life Insurance
Short-term and Long-term Disability
Matching 401(k) Contributions
Vacation and Paid Sick Time
Tuition Reimbursement
Pay Range (Applicable to Massachusetts)$107,900.00 USD - $148,400.00 USD AnnualJob CategoryQuality
Is Sponsorship Available?
No
JetCool is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We do not discriminate based on: age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status, or any other status protected by law. We're happy to provide reasonable accommodations to those with a disability for assistance in the application process. Please email accessibility@flex.com and we'll discuss your specific situation and next steps (NOTE: this email does not accept or consider resumes or applications. This is only for disability assistance. To be considered for a position at JetCool, you must complete the application process first).
Auto-ApplyDirector, Regulatory Affairs and Quality Assurance
Quality assurance manager job in Boston, MA
WHOOP is an advanced health and fitness wearable on a mission to unlock human performance and healthspan. We empower our members to improve their health and perform at a higher level through a deeper understanding of their bodies and daily lives. As the Director of Regulatory Affairs & Quality Assurance (RA/QA), you will lead the strategy, execution, and continuous evolution of WHOOP's regulatory and quality frameworks as we expand deeper into regulated digital health and medical-grade product capabilities. You will also play a critical role in strengthening WHOOP's design quality discipline, ensuring robust design controls, risk management, and design quality practices. You will shape the regulatory pathway for our next generation of health features, ensure compliance across global markets, and build systems that enable WHOOP to scale medical device development responsibly and efficiently.
This role is ideal for a seasoned RA/QA leader who thrives in fast-paced, cross-functional environments and is motivated by the opportunity to help define the future of WHOOP as a health technology company.
QUALIFICATIONS:
* Lead regulatory strategy for WHOOP's health features and regulated products from development through approval and lifecycle management.
* Oversee regulatory submissions including 510(k), De Novo, technical files, global registrations, providing strategic direction, final review, and cross-functional alignment.
* Serve as WHOOP's primary liaison with regulatory agencies and notified bodies.
* Interpret and communicate regulatory requirements to cross-functional teams, ensuring seamless integration throughout the development lifecycle.
* Oversee WHOOP's Quality Management System (QMS) to ensure compliance with FDA, ISO 13485, MDR, and other global regulatory frameworks.
* Provide leadership and oversight for Design Quality Engineers responsible for DHF maintenance, design reviews, risk management (ISO 14971), verification/validation strategy, and software change control processes.
* Lead internal and external audit readiness, including FDA inspections and notified body audits.
* Manage post-market surveillance and adverse event reporting.
* Review marketing and promotional materials for regulated and general wellness features to ensure compliance.
* Build, manage, and mentor a high-performing team.
* Monitor regulatory changes, evolving standards, and industry trends, advising leadership on implications and opportunities.
RESPONSIBILITIES:
* Bachelor's degree in life sciences, engineering, regulatory affairs, or a related field; advanced degree preferred.
* 8+ years of regulatory affairs experience in medical devices, digital health, wearables, or related fields.
* Proven experience leading successful FDA submissions (510(k), De Novo) and managing global regulatory approvals.
* Demonstrated success building or overseeing a Quality Management System, including experience with external audits.
* Deep understanding of software as a medical device (SaMD), cybersecurity considerations, post-market requirements, and applicable standards.
* Strong working knowledge of ISO 14971 risk management, including hazard analysis, FMEAs, risk/benefit justification, and integration of risk controls across hardware, firmware, and software.
* Experience overseeing post-market quality activities, including complaints, MDR/Vigilance assessments, field actions, and design updates based on post-market signals.
* Working knowledge of privacy and data regulations such as HIPAA and GDPR.
* Exceptional communication, leadership, and stakeholder management skills.
* Ability to thrive in a fast-paced, high-growth environment with evolving priorities.
* Experience navigating the boundary between general wellness and SaMD, including evaluating feature intent, regulatory risk, and appropriate evidence pathways.
It is strongly preferred that the candidate is able to work out of the WHOOP office located in Boston, MA.
Interested in the role, but don't meet every qualification? We encourage you to still apply! At WHOOP, we believe there is much more to a candidate than what is written on paper, and we value character as much as experience. As we continue to build a diverse and inclusive environment, we encourage anyone who is interested in this role to apply.
WHOOP is an Equal Opportunity Employer and participates in E-verify to determine employment eligibility. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
The WHOOP compensation philosophy is designed to attract, motivate, and retain exceptional talent by offering competitive base salaries, meaningful equity, and consistent pay practices that reflect our mission and core values.
At WHOOP, we view total compensation as the combination of base salary, equity, and benefits, with equity serving as a key differentiator that aligns our employees with the long-term success of the company and allows every member of our corporate team to own part of WHOOP and share in the company's long-term growth and success.
The U.S. base salary range for this full-time position is $220,000-$245,000. Salary ranges are determined by role, level, and location. Within each range, individual pay is based on factors such as job-related skills, experience, performance, and relevant education or training.
In addition to the base salary, the successful candidate will also receive benefits and a generous equity package.
These ranges may be modified in the future to reflect evolving market conditions and organizational needs. While most offers will typically fall toward the starting point of the range, total compensation will depend on the candidate's specific qualifications, expertise, and alignment with the role's requirements.
Learn more about WHOOP.
Director, Regulatory Affairs & Quality Assurance - medical device
Quality assurance manager job in Burlington, MA
InnoTECH Staffing is looking to hire a fulltime permanent Director of Regulatory Affairs & Quality Assurance (RA/QA) for an exciting and growing medical device company in Burlington, MA. Candidate must be local and be able to go to office a few days a week.
Must be a US Citizen or Greencard Holder!
Our client is a medical device manufacturer committed to advancing cancer therapy through research, engineering, high-quality products, and exceptional physician support.
We are seeking a Director of RA/QA to lead all regulatory affairs and quality assurance activities for the company as they continue to expand their global presence and product portfolio.
90% of this role is internal and external audits, dealing with findings, CAPAs, updating procedures, returns, non conformities.
10% new submissions / regulatory approval in countries outside the US.
Job Description
· Lead, manage, and develop the Regulatory Affairs and Quality Assurance functions to ensure organizational compliance with global medical device regulations and standards.
· Oversee the development, implementation, and continuous improvement of the company's Quality Management System (QMS) in accordance with ISO 13485, FDA 21 CFR Part 820, and other applicable regulatory frameworks.
· Direct internal GMP/QSR audits and manage external audits from regulatory agencies, notified bodies, and key customers.
· Lead the preparation, submission, and maintenance of device regulatory submissions including EU MDR Technical Documentation, 510(k) applications, FDA listing/registration, and international market authorizations.
· Oversee and ensure compliance with complaint handling, medical device reporting (MDR/Vigilance), field corrections/recalls, and import/export regulatory requirements.
· Direct the creation, execution, and maintenance of internal and supplier quality audits; ensure suppliers meet regulatory and company quality expectations.
· Oversee product and process validation programs, including IQ/OQ/PQ activities, ensuring that products are consistently manufactured to specifications and compliant with regulatory expectations.
· Provide strategic regulatory input for new product development, design changes, and lifecycle management activities.
· Serve as the primary liaison with regulatory authorities, notified bodies, and external partners regarding regulatory and quality matters.
· Lead RA/QA daily operations including CAPA management, risk management activities (ISO 14971), document control, training, and quality metrics reporting.
· Advise executive leadership on regulatory strategy, quality trends, risk factors, and compliance status to support business objectives.
Education / Experience Requirements
· Bachelor's degree in a scientific or engineering discipline; advanced degree preferred.
· 8+ years of experience in FDA and EU medical device Regulatory Affairs and Quality Assurance, with demonstrated expertise in global regulatory requirements and quality system standards.
· Minimum of 5 years of medical device quality assurance experience with strong working knowledge of ISO 13485 and FDA QSR.
· Experience in preparing and managing regulatory submissions (e.g., 510(k), EU MDR) and supporting regulatory audits/inspections.
· Excellent organizational, leadership, interpersonal, and communication skills.
· Demonstrated success in a hands-on, fast-paced, cross-functional medical device environment.
Specialized Skills / Other Requirements
· Strong understanding of risk/benefit analysis, product safety principles, and regulatory science applicable to interventional medical devices.
· Proven ability to effectively manage multiple complex projects and enforce timelines in a growing organization.
· Strong technical writing skills and the ability to create clear, compliant regulatory and quality documentation.
· Ability to collaborate across departments including R&D, Manufacturing, Operations, Clinical, and Marketing.
· 10% to 25% travel may be required for audits, regulatory meetings, and supplier visits.
· Self-starter with excellent attention to detail and the ability to follow through on commitments.
Full-time position with competitive compensation, medical/dental insurance, 401(k), and professional development opportunities.
Director, Clinical Quality Assurance
Quality assurance manager job in Boston, MA
At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.
Director, Clinical Quality Assurance
The Director, Clinical Quality Assurance position is responsible for design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the Quality management system. This role is responsible for Good Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai's Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (e.g. US, EU Directives, US FDA, PMDA, ICH).
Essential Functions
* Independently conduct audits
* Review and oversee results of CQA audits of study sites, clinical vendors, clinical documents, and internal process audits
* Facilitate Sponsor health authority inspections of global clinical facilities and study sites
* Continuously drive innovation through active search, evaluation, acquisition, and implementation of high-impact new technologies/ procedures across clinical quality programs
* Direct skill-building interventions for CQA staff through cross-functional/ external partnerships to reskill/ upskill and adapt the workforce to evolving technologies.
* May be responsible for direct people management including goal setting, performance management, development, and engagement.
Requirements
* Bachelor's degree in an associated functional discipline (advanced degree preferred) with minimum 12 years in clinical research/ operations/ data management or related area.
* 5+ years of experience in GCP auditing.
* Substantial experience in inspection management.
* Substantial experience with US, EU, and international regulatory standards and guidelines for the conduct of clinical trials.
* Demonstrated ability to operate and influence decision-making processes
* Effective communication skills
* Successful track record of supervising employees and managing cross-cultural differences
* Technical and administrative capabilities to independently carry out routine, complex and for-cause audits
* Knowledge of data integrity controls and systems quality for clinical area
* Strong analytical skills and report writing skills
* Experience with GxP systems including computer system validation and associated regulations, recommended.
* Ability to Travel (approximately 20%)
* Candidates near Eisai's NJ/PA location will be preferred. For candidates near an Eisai location, Remote Work Arrangement will consist of 2-4 days in office (Nutley/Exton) per month and 1-2 audits quarterly; remote audits, are held in Nutley. CQA is also expected to be present in Nutley for any inspections or critical inspection mgmt. activities.
Eisai Salary Transparency Language:
The base salary range for the Director, Clinical Quality Assurance is from :195,000-256,000
Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan.
Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.
Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit ***********************************************
Certain other benefits may be available for this position, please discuss any questions with your recruiter.
Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:
Right To Work
E-Verify Participation
Auto-ApplyQuality Assurance Coordinator
Quality assurance manager job in Manchester, NH
Full-time Description
To provide quality assurance and administrative supports to the day program management team, specifically to ensure the accuracy of documentation related to annual certification.
PAY: $20/hr.
Essential Responsibilities:
Review daily and monthly documentation and billing for accuracy and compliance with state regulations
Track and order building and office supplies
Track, schedule and follow up on all van maintenance
Monitor all building maintenance concerns and report to facility manager
Train new hires on documentation systems
Maintain certification files and execute annual certification review with state certifiers
Qualifications:
Education and Experience
High school diploma or equivalent required
1-2 years' experience in the field of developmental services preferred
Experience with writing and reviewing documentation for quality and accuracy in a human services setting preferred
Proficiency in Microsoft Office Suite and database systems
Valid driver's license and access to a safe operating vehicle during scheduled working hours
Skills and Abilities
Ability to work both independently and collaboratively as part of a team
Maintains high attention to detail
Strong computer literacy (including but not limited to proficiency with word processing, spreadsheets, email, and database software-MS Office)
Ability to multi-task and meet deadlines under very specific timeframes
Maintains a high level of organization
Ability to communicate effectively (reading, writing, speaking) in English
Strong customer services skills
Ability to work well under pressure
Note: The Moore Center considers the ability to speak, read and write English an essential functions of all positions. Training requirements, essential responsibilities and the physical requirements listed are considered essential to ensure the safety and well-being of the clients we serve. We will consider alternate methods of accomplishing tasks to accommodate any physical limitation(s) an employee might have. In an emergency, all staff may be required to perform activities that are above and beyond what is indicated on this job description to ensure the safety of the individuals we serve.
All staff must adhere to the NH state law requiring mandated reporting of suspected abuse, neglect, or exploitation. Additionally, staff are required to maintain criminal, motor vehicle, DCYF, OIG, and Bureau of Elderly and Adult Services record checks that meet agency standards. Staff are also required to travel and transport clients when applicable. This includes having access to a reliable vehicle, a valid driver's license and maintaining comprehensive personal auto insurance of $100,000/300,000.
Salary Description $20/hr.
Construction Quality Control Manager
Quality assurance manager job in Manchester, NH
We are looking for an experienced Construction Quality Control Manager to join our team. This role is responsible for developing, implementing, and managing quality control systems to ensure that construction activities and outputs comply with project specifications, company standards, and regulatory requirements. This role is critical in ensuring the delivery of high-quality of DEW Construction's projects through oversight, inspection, and coordination with project teams, subcontractors, and third-party inspectors.
DEW's Vision, Mission, and Core Values:
Vision Statement: To be the go-to construction partner known for our unwavering commitment to the success of every project.
Mission Statement: To build a team of professionals who share our core values and foster a culture where everyone can thrive and grow together.
Core Values:
Optimism: We share a positive mindset, believing in opportunities over obstacles.
Initiative: We are self-motivated, proactive problem solvers.
Accountability: We are committed to a culture of ownership, personal accountability, and safety.
DEW's Vision, Mission, and Core Values are explicitly integrated into our daily decision-making, leadership behaviors, employee training, performance evaluations, and company culture. We use them as a guiding principle for all activities and hold employees accountable for upholding them, essentially making them a tangible part of the company's identity and operations. Our aim is to ensure we are aware of these guiding principles and feel motivated and encouraged to continue integrating them into our daily lives
Essential Functions:
Quality Assurance Program Development:
Develop and maintain project-specific Quality Control Plans (QCPs).
Ensure construction compliance with applicable project documents (Plans, Specifications, submittals, standards, regulations, and customer requirements.
Lead quality meetings and contribute to project pre-construction planning efforts.
Inspection and Testing:
Oversight and documentation of inspections, materials, workmanship, and final products.
Coordinate and document third-party testing and special inspections.
Identify and correct deficiencies with the project team utilizing Procore Observations to document deficiencies and non-compliant work as well as corrective action plans.
Documentation and Reporting:
Maintain detailed and organized quality records, including inspection logs, test reports, and compliance certifications.
Prepare and submit daily quality reports and project QA/QC status updates.
Review and approve subcontractor and supplier quality documentation.
Team Leadership and Communication:
Serve as the primary point of contact for quality control matters on the job sites for the Project Teams.
Train and mentor construction staff and subcontractors on quality standards and procedures.
Facilitate communication between project management, clients, regulatory agencies, and contractors.
Prepare monthly QAQC Reports to identify areas of concern, compliance, recommendations to improve performance.
Continuous Improvement:
Analyze quality trends and data to identify opportunities for process improvement.
Recommend and implement best practices to enhance overall construction quality.
Essential Experience:
Education:
Bachelor's degree in Civil, Mechanical, or Structural Engineering, Construction Management, or related field preferred. Equivalent experience may be considered.
Experience:
Minimum 5-7 years of experience in construction quality control, preferably in commercial, industrial, or federal/military projects or requisite field experience.
Prior experience with government contracts (e.g., USACE/NAVFAC) is a plus.
Certifications (Preferred):
USACE Construction Quality Management (CQM) Certification
OSHA 30-Hour Certification
ACI, ICC, or other relevant technical certifications
Skills & Abilities:
Strong knowledge of construction methods, materials, standards, and regulations.
Excellent attention to detail, organizational, and analytical skills.
Proficient in reading and interpreting blueprints and specifications.
Strong written and verbal communication skills.
Proficiency with MS Office and construction management software (Procore, Primavera, Bluebeam).
If you are interested in being part of an innovative and collaborative team, in a challenging and rewarding work environment, we want to hear from you! We are always trying to stay a step ahead of emerging trends in the industry. Every employee is part of the process and part of our success. DEW's philosophy is to invest in people and inspire them to bring the best of themselves to work every day. In addition to offering competitive wages and a comprehensive benefits package, employees are given opportunities to learn, develop and grow. These are the reasons DEW is named amongst the top places to work in New Hampshire and Vermont.
We are an Equal Opportunity Employer.
Program Manager - Clinical Quality Management (Infectious Disease Bureau)
Quality assurance manager 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
Biomedical Education QA Engineering Coordinator
Quality assurance manager job in Boston, MA
Site: The Brigham and Women's Hospital, Inc. Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.
Job Summary
Summary
Responsible for building, providing, coordinating, and, facilitating comprehensive training and education on the use, maintenance, and troubleshooting of biomedical equipment to BME technical staff.
Does this position require Patient Care? No
Essential Functions
* Develop, deliver, coordinate, and facilitate training programs on the use and maintenance of biomedical equipment, including but not limited to diagnostic, therapeutic, and monitoring devices.
* Develop and update training materials, user guides, and standard operating procedures (SOPs) for various biomedical devices and technologies. Ensure training programs are aligned with the latest industry standards, safety regulations, and healthcare protocols.
* Provide and facilitate practical, hands-on training sessions, demonstrating how to properly set up, operate, and troubleshoot biomedical equipment. Ensure participants achieve competency in equipment use to enhance patient outcomes.
* Stays up to date on new technologies, product updates, and advancements in biomedical engineering.
* Ensure that all training content adheres to healthcare regulations, safety standards, and compliance guidelines (e.g., FDA, OSHA).
* Evaluate the effectiveness of training programs through assessments, feedback, and observation. Identify areas for improvement and adjust training programs to ensure participants meet required proficiency levels.
* Work closely with biomedical engineering teams, medical device manufacturers, and technical staff to ensure smooth integration of biomedical equipment into healthcare operations.
Qualifications
Education
Bachelor's Degree Biomedical Engineering required or Bachelor's Degree Related Field of Study required
Can this role accept experience in lieu of a degree?
Yes
Licenses and Credentials
Experience
Experience in biomedical equipment or other closely related role 3-5 years required and Experience in training, staff development, or other related role 1-2 years preferred
Knowledge, Skills and Abilities
* Strong technical understanding of biomedical equipment, such as diagnostics, patient monitoring, and therapeutic devices.
* Excellent communication and presentation skills, with the ability to convey complex technical concepts to non-technical audiences.
* Proficiency in Microsoft Office Suite (PowerPoint, Word) and familiarity with training software or learning management systems (LMS).
* Problem-solving skills with an ability to troubleshoot and resolve technical issues in real time during training sessions.
Additional Job Details (if applicable)
Physical Requirements
* Standing Frequently (34-66%)
* Walking Frequently (34-66%)
* Sitting Occasionally (3-33%)
* Lifting Frequently (34-66%)
* Carrying Frequently (34-66%)
* Pushing Occasionally (3-33%)
* Pulling Occasionally (3-33%)
* Climbing Rarely (Less than 2%)
* Balancing Frequently (34-66%)
* Stooping Occasionally (3-33%)
* Kneeling Occasionally (3-33%)
* Crouching Occasionally (3-33%)
* Crawling Rarely (Less than 2%)
* Reaching Frequently (34-66%)
* Gross Manipulation (Handling) Frequently (34-66%)
* Fine Manipulation (Fingering) Frequently (34-66%)
* Feeling Constantly (67-100%)
* Foot Use Rarely (Less than 2%)
* Vision - Far Constantly (67-100%)
* Vision - Near Constantly (67-100%)
* Talking Constantly (67-100%)
* Hearing Constantly (67-100%)
Remote Type
Hybrid
Work Location
100 Blossom Street
Scheduled Weekly Hours
40
Employee Type
Regular
Work Shift
Day (United States of America)
Pay Range
$92,102.40 - $134,056.00/Annual
Grade
7
At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package.
EEO Statement:
The Brigham and Women's Hospital, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************.
Mass General Brigham Competency Framework
At Mass General Brigham, our competency framework defines what effective leadership "looks like" by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.
Auto-ApplySupplier Quality Clinic Manager (Onsite)
Quality assurance manager job in North Berwick, ME
Country:
United States of America Onsite
U.S. Citizen, U.S. Person, or Immigration Status Requirements:
U.S. citizenship is required, as only U.S. citizens are authorized to access information under this program/contract.
Security Clearance:
None/Not Required
Pratt & Whitney is working to once again transform the future of flight-designing, building and servicing engines unlike any the world has ever seen. And because transformation begins from within, we're seeking the people to drive it. So, calling all curious.
Come ready to explore and you'll find a place where your talent takes flight-beyond the borders of title, a country or your comfort zone. Bring your passion and commitment and we'll welcome you into a tight-knit team that takes our mission personally. Channel your drive to make a difference into shaping an organization and an industry that's evolving fast to the future.
At Pratt & Whitney, the difference you make is on display every day. Just look up. Are you ready to go beyond?
What You Will Do:
The North Berwick Supplier Quality Clinic is a challenging, fast paced, and high visibility environment. The Supplier Quality Clinic Manager will manage the Quality Clinic with a high level of integrity to effectively manage cross-functional relationships to drive and support a high performing team.
Leadership of the Supplier Quality team focused on Quality Improvement and flawless execution of the Quality Clinic process
Responsible for timely and compliant ownership and resolution of all Escapes Management Investigations and actions to include issuance and closure of escapes, requesting 6015s when required, requesting IROs as necessary and follow up through closure, and verification of implementation of escape corrective actions to due date(s); maintain oversight of the organization's Escape Management Process
Responsible for timely and compliant ownership and resolution of Customer Returns Investigations and other clinic to clinic investigations.
Present details of Escapes and providing updates to Quality and Ops leadership and Customers as required, including the DCMA.
Manage timely processing of restricted inventory; support Metrics and Control Tower reporting activities
Maintain personal and team CORE discipline certifications/training
Optimize the Quality Clinic's efficiency and robustness; foster and maintain cooperative relationship with Program Quality, Product Recall, DCMA, and leverage clinic to clinic interaction across the enterprise; enhance personal and team competency in RCCA
Support Production Tier 4 & 5 Gemba - Manufacturing Standard Work:
Collaborate with shop quality, engineering support to operations, materials, procurement, and other plant leadership / stakeholders.
Qualifications You Must Have:
Bachelor's degree and minimum 8 years experience in an engineering, manufacturing operations, quality or closely related industrial environment or a Master' degree and minimum 5 years experience in an engineering, manufacturing operations, quality or closely related industrial environment
In absence of a degree, 12 or more years experience in an engineering, manufacturing operations, quality or closely related industrial environment
Experience in a team lead/supervisory capacity
Experience with the Escapes Management Process and Quality Clinic Process
Understanding of Root Cause/Corrective Action (RCCA)
Experience with Microsoft Excel, PowerPoint, and SAP
U.S. citizenship is required, as only U.S. citizens are authorized to access information under this program/contract
Qualifications We Prefer:
Experience creating and delivering presentations
Certification in Red-X / 6 Sigma / similar data driven problem solving approach preferred
Demonstrated ability to manage customer concerns, process commitments and meeting customer deliverables
Learn More & Apply Now:
In addition to transforming the future of flight, we are also transforming how and where we work. We've introduced role types to help you understand how you will operate in our blended work environment. This role is:
Onsite: Employees who are working in Onsite roles will work primarily onsite. This includes all production and maintenance workers, as they are essential to the development of our engines.
As part of our commitment to maintaining a secure hiring process, candidates may be asked to attend select steps of the interview process in-person at one of our office locations, regardless of whether the role is designated as on-site, hybrid or remote.
The salary range for this role is 101,000 USD - 203,000 USD. The salary range provided is a good faith estimate representative of all experience levels. RTX considers several factors when extending an offer, including but not limited to, the role, function and associated responsibilities, a candidate's work experience, location, education/training, and key skills.Hired applicants may be eligible for benefits, including but not limited to, medical, dental, vision, life insurance, short-term disability, long-term disability, 401(k) match, flexible spending accounts, flexible work schedules, employee assistance program, Employee Scholar Program, parental leave, paid time off, and holidays. Specific benefits are dependent upon the specific business unit as well as whether or not the position is covered by a collective-bargaining agreement.Hired applicants may be eligible for annual short-term and/or long-term incentive compensation programs depending on the level of the position and whether or not it is covered by a collective-bargaining agreement. Payments under these annual programs are not guaranteed and are dependent upon a variety of factors including, but not limited to, individual performance, business unit performance, and/or the company's performance.This role is a U.S.-based role. If the successful candidate resides in a U.S. territory, the appropriate pay structure and benefits will apply.RTX anticipates the application window closing approximately 40 days from the date the notice was posted. However, factors such as candidate flow and business necessity may require RTX to shorten or extend the application window.
RTX is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or veteran status, or any other applicable state or federal protected class. RTX provides affirmative action in employment for qualified Individuals with a Disability and Protected Veterans in compliance with Section 503 of the Rehabilitation Act and the Vietnam Era Veterans' Readjustment Assistance Act.
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