Engineering Structures Jobs in Winchester Middlesex County, MA

COMPENSATION & EARNINGS

• Base Salary: $75,000-$85,000 per annum
• 1st Year Total On-Target Earnings (OTE): $125,000 per annum (base + performance incentives)

At Leyton, we’re not your average consulting firm. We’re a team of passionate innovators, financial strategists, and opportunity creators helping businesses of all sizes reach their full potential. As we continue our rapid growth in North America, we’re looking for a results-driven Business Development Executive to join our high-performing U.S. sales team.

About Leyton

Leyton is a global consulting firm dedicated to helping businesses improve performance through innovation funding and underutilized tax strategies. Since 1997, we have grown to more than 3,000 employees across 17 countries, with U.S. offices in Boston and San Francisco. Our U.S. presence provides the agility of a startup combined with the stability and resources of an established global company.

In the United States, our expertise includes Research and Development (R&D) Tax Credits, State and Local Tax (SALT), Energy Efficiency Credits, Cost Segregation, and more. Our consultants, technical experts, and tax specialists provide strategic advice on how best to utilize credits, incentives, and refunds. Our sales and strategic teams have built strong relationships with firms across more than 70 niche markets. To date, Leyton has helped over 25,000 companies uncover tax credits and reinvest in innovation and business growth.

What You’ll Do

As a Business Development Executive/Account Executive, your mission is to generate new business opportunities in the USA, targeting businesses operating in the innovation space. You will be supported by a collaborative inside sales team, both onshore and offshore, and work closely with our consultants and leadership teams to drive results.

Key Responsibilities

• Identify, pursue, and close new business opportunities through market research, networking, and strategic outreach
• Build and manage a robust pipeline while nurturing relationships with key stakeholders
• Own the full sales cycle from prospecting and meeting decision-makers to closing deals and onboarding
• Develop and present tailored value propositions that address client challenges and deliver measurable results
• Collaborate with consultants, internal teams, and partners to drive referrals and maximize client impact
• Train and coach the inside sales team to generate qualified leads aligned with your strategy
• Support the development and execution of regional go-to-market strategies
• Meet and exceed monthly KPIs and annual revenue targets
• Manage existing client accounts with a focus on retention and expansion

What We’re Looking For

• Proven experience selling Tax Credits, tax advisory, and State and Local Tax (SALT) solutions to U.S. companies is considered a strong asset.
• Quota-achieving sales experience in a closing role
• Consultative selling skills, with the ability to tailor solutions to client needs
• High-volume outreach expertise with a strategic prospecting approach
• Ability to engage C-level executives and key stakeholders with confidence and credibility
• Outstanding communication and persuasion skills, with strong pitching and negotiating ability
• Self-motivated, disciplined, and goal-oriented with strong organizational skills

Nice-to-Haves

• Bachelor’s degree in Business Administration, Management, Marketing, or a related field
• Experience with Salesforce and SalesLoft or similar CRMs
• Background in selling intangible products or services
• Formal sales methodology training

Required Skills and Qualifications

• 3-5 years of experience selling services to mid- and high-market clients
• Proven track record in consultative sales and managing the full sales cycle
• Experience working with or selling for a management consulting firm is a strong asset
• Background in finance, innovation, or operations is an advantage
• Highly self-motivated, independent, and results-oriented
• Excellent verbal and written communication skills
• Strong interpersonal skills and a collaborative mindset
• A high level of professionalism, integrity, and ethical standards

What We Offer

Compensation

• Base Salary: $75,000-$85,000 per annum plus , Commission: Up to $55,000.
• 1st Year Total On-Target Earnings (OTE) for this role: $125,000 per annum (on an average).
• Uncapped Commission and Strong Quarterly Bonuses
• Competitive annual salary structure with performance-based incentives

Growth and Development

• Access to exclusive international training programs through Leyton Academy
• Defined career paths and mentorship within a fast-growing, global organization
• Mentorship and guidance from experienced sales leadership and consulting professionals.

Flexibility and Culture

• Hybrid work model with 3 days per week in a collaborative office setting
• Fun quarterly team events and a supportive, inclusive workplace environment
• Volunteer and community engagement opportunities
• Exposure to executive leadership and subject matter experts

Benefits (U.S. Employees)

• Competitive base salary plus performance-based bonus structure.
• Starting with four weeks of vacation.
• 401(k) with employer matching.
• Medical, dental, vision, prescription, and paramedical coverage.
• Healthcare FSA and HRA
• Paid holidays, vacation, and sick leave (compliant with state and local law)
• Complimentary time off in the summer and at Christmas
• Summer Fridays (half days in July and August)

Physical Requirements

• Prolonged periods of sitting at a desk and working on a computer
• Must be able to lift up to 15 pounds occasionally
• Reasonable accommodations are available as required by law

Equal Employment Opportunity

Leyton provides equal employment opportunities to all employees and applicants. Discrimination or harassment of any kind is strictly prohibited. Employment decisions are made without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, genetics, or any other protected characteristic under federal, state, or local law.

This policy applies to all employment practices, including recruitment, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

LOCATION:

Boston, MA

OVERVIEW:

Our client is searching for a Summer 2026 Private Equity Associate based in Boston, MA. The Associate will support the investment process and meaningfully contribute to all facets of a deal process including; industry research and deal evaluation, financial modeling, valuation analysis, transaction structuring and negotiation, investment committee approval process, and pre and post-merger due diligence.

ROLE RESPONSIBILITIES:

The Associate role involves performing a wide variety of tasks and analysis in direct support of the team. Specific responsibilities include:

• Assist in the management of all aspects of investment evaluation and execution, including meetings with management, oversight of 3rd-party advisors, and discussions with financing sources
• Lead industry, business, and financial diligence efforts
• Lead transaction structuring and modeling efforts
• Work with portfolio company management teams to monitor performance; identifying and driving value-creation initiatives post-close

REQUIREMENTS:

• 1-4 years of experience in investment banking or private equity
• Exceptional analytical skills, including quantitative analysis and complex modeling skills
• Exceptional interpersonal and communication skills; able to articulate ideas to both technical and non-technical audiences
• Independently holds self to the highest standards of integrity, honesty, and forthrightness
• Highly motivated and entrepreneurial; possessing a high degree of personal initiative

#2588 IT Business Partner - GMP Manufacturing Operations

Company and Role

Company is a publicly traded global pharmaceutical company with strong roots in the United States.

The IT Business Partner - GMP Manufacturing Operations will lead all technology implementation, production support, and maintenance activities within the Manufacturing Suite, ensuring systems are reliable, secure, and compliant with GMP and GxP requirements. This position will be responsible for authoring and enforcing SOPs to meet GMP guidelines, onboarding new equipment, maintaining compliance of existing systems, and driving the implementation of new IT GxP solutions such as Data Historian and LIMS.

Expectations

• Own and foster the IT-to-business relationship for Manufacturing operations, ensuring alignment of technology strategy with manufacturing leadership priorities.
• Define and manage a support and operating model for the Manufacturing Suite, maintaining application production environments to quality standards and delivering high-value implementation projects on time and on budget.
• Lead a team of internal and external, onshore and offshore IT professionals to execute implementation and support activities, ensuring SLA adherence and customer satisfaction.
• Provide oversight and expertise in Manufacturing change control, deviation management, and CAPA processes to ensure IT systems support regulatory and quality expectations; and proficient in tools like Veeva Vault, TrackWise Digital.
• Work closely with the Process Automation (PA) group to define clear roles and responsibilities between IT and PA, ensuring seamless collaboration and system ownership across both functions.
• Manage partner/vendor relationships, ensuring external service providers deliver quality and performance according to service levels and regulatory requirements.
• Develop, write, and enforce Standard Operating Procedures (SOPs) to ensure adherence to GMP guidelines across all IT-supported manufacturing processes.
• Oversee onboarding of new equipment into Manufacturing Suite, ensuring systems are validated, compliant, and maintained according to regulatory standards.
• Maintain compliance of all existing equipment and IT systems, ensuring continuous alignment with GMP and GxP requirements.
• Lead implementation of new IT GxP systems within the suite (e.g., Data Historian, MES, LIMS), ensuring proper validation, integration, and ongoing support.
• Ensure adherence to regulatory requirements (FDA, GxP), cybersecurity standards, and departmental policies, practices, and SOPs.
• Partner with global and local IT management to align best practices across Company, introducing process improvements and leveraging industry learnings.

Experience

• Bachelor’s degree in computer science, Information Systems, Engineering, or related field.
• Minimum of ten (10) years’ IT experience supporting pharmaceutical manufacturing suite or with at least 5 years in technical leadership roles.
• Proven experience managing IT vendor relationships and service providers in a regulated environment.
• Demonstrated expertise in GMP and GxP compliance, including authoring, maintaining, and enforcing SOPs for IT systems supporting manufacturing operations.
• Demonstrated experience in configuring IT components for manufacturing equipment and writing user requirements
• Strong background in equipment onboarding, validation, and lifecycle management to ensure systems remain compliant and audit-ready.

Preferred Experience

• Hands-on experience with ERP, Data Historian, Laboratory Information Management Systems (LIMS), and other GxP manufacturing support technologies.
• Hands -on experience: onboarding and installing pharmaceutical manufacturing equipment, configuring the systems for the equipment and writing the user requirements.

Benefits

• Medical, Dental, Vision benefits
• Short Term and Long Term Disability
• Generous PTO, Holiday Schedule and Company Shut Downs
• Annual Bonus Potential
• Recipient of “Best Places To Work” multiple times for a positive corporate culture.

OPT Industries ( ) is a venture-backed MIT spinoff company that is focused on building the next generation of additive manufacturing technology. Working at the intersection of automation engineering, computational design, and polymer science, we design and commercially manufacture highly customizable materials and products – everything from electrical components to luxury fashion.

Position Summary: Own and improve the reliability of production equipment by troubleshooting and sustaining electromechanical, controls, and firmware-adjacent systems across OPT’s manufacturing floor.

Key Responsibilities:

• Own and develop Python-based control, test, and automation systems.
• Debug and extend ATMega embedded C/C++ (incl. hardware-software interfaces, IP networks)
• Build and maintain hardware-software interfaces for sensors, motors, actuators, and data acquisition systems.
• Design test infrastructure, logging, and fault detection to support production uptime and repeatability.
• Update equipment, documentation, training, and maintenance procedures to prevent recurrence
• Support troubleshooting and urgent production issues on aggressive timelines

Qualifications:

• 5+ years of relevant experience, or 3+ years plus a Master’s degree in robotics, mechatronics, EE, CS, or a related field.
• Strong Python background with experience in hardware control, automation, or test systems.
• Hands-on experience with electromechanical systems: motors, encoders, sensors, power electronics, and control loops.
• Working knowledge of embedded C for microcontroller-based systems
• Comfortable using Bash / Linux environments for scripting, debugging, and system operations.
• Experience supporting systems in a production or manufacturing environment is a strong plus.

OPT Industries is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

About the Role

Join our dynamic R&D team as a Quality Control Inspector. In this role, you’ll play a critical role in ensuring that our Pulse IVL System product meets established quality standards and specifications at various points in the organization while advocating for strict adherence to compliance practices within the facility.

Key Responsibilities

• With minimal supervision, performs incoming, in-process, and final inspections of components and finished device.
• Interprets quality inspection documents and deciphers quality expectations for the product.
• Approves products by confirming specifications, conducting visual and measurement tests, returning products for re-work and confirming re-work
• Monitors use of equipment to ensure it is calibrated before use; keeps measurement equipment operating accurately
• Performs and documents results of inspections per company procedures.
• Responsible for initiating non-conformance reports and ensuring non-conforming material is processed in accordance with the disposition. May assist with nonconformance investigations as needed.
• Review and verify documentation for compliance with specifications and regulatory requirements (e.g., FDA, ISO 13485).
• Maintain accurate inspection records and support traceability and documentation control.
• Collaborate with engineering and manufacturing teams to identify and resolve quality issues.
• Assist in root cause analysis and corrective/preventive actions (CAPA).
• Support internal audits and regulatory inspections.
• Ensure calibration and maintenance of inspection tools and equipment.

Required Qualifications

• Associate or bachelor’s degree in business, supply chain, life sciences or other scientific field or equivalent work experience (3-5 years).
• 3+ years of experience in quality inspection in the medical device industry.
• Strong understanding of quality systems and regulatory standards (ISO 13485, FDA 21 CFR Part 820).
• Proficiency in using inspection tools (calipers, micrometers, gauges, vision systems) and reading technical drawings/specifications.
• Excellent attention to detail and documentation skills.
• Ability to work independently and as part of a cross-functional team.
• Strong communication and problem-solving skills.
• Experience with electronic documentation systems (e.g., eQMS).
• Familiarity with cleanroom protocols and GMP practices.
• ASQ certification (e.g., CQI) is a plus.
• Two (2) or more years of laboratory experience
• Experience in QC inspection, cleanroom manufacturing, and medical device start-up
• 3+ year of Quality Control Experience in Medical Device Manufacturing. Knowledge of clean room operations
• Understanding of a quality management system (QMS) and cGMP knowledge
• Proficient level with Microsoft Office (Outlook, Excel, PowerPoint, and Word)
• Knowledge of Non-Conformance Reports (NCRs)

ABOUT US

Syniti, part of Capgemini, tackles the hardest work in data for the world’s largest organizations. We combine intelligent software with deep data expertise to help the Fortune2000 tackle complex data challenges and drive measurable business outcomes with business-ready data.

Syniti’s Data First strategy transforms data from an afterthought into a strategic asset—unlocking insights, reducing risk, and fueling growth. With over 5,000 successful projects, we support the full data lifecycle through a unified platform for migration, quality, replication, matching, master data management, analytics, governance, and strategy.

Operating globally across industries, Syniti’s award-winning software, expert consultants give enterprises a unique edge in managing and maximizing their data.

THE ROLE

The Client Account Executive role focuses exclusively on formulating and executing a sales strategy within an assigned territory, resulting in revenue growth and new customer acquisition. This is a quota-carrying role, responsible for acquiring, expanding, and managing large accounts. A successful candidate will be self-motivated, highly driven, goal-oriented, and methodical. Demonstrated success and know-how across the full sales cycle from qualification to contract close is critical to success in this role.

The Client Account Executive will focus on software and services sales ultimately driving our customer’s success.

This role can be remote-based in the US (East).

WHAT YOU WILL DO

• Prospect, develop, and close new business while ensuring we have satisfied and referenceable customers.
• Sell a complete solution of software, services, and support to ensure customer success.
• Active territory management targeting specific companies and collaborating with select partners to drive incremental pipeline.
• Manage complex, enterprise-wide wide sales-cycles and effectively present our value proposition.
• Work methodically with Marketing to develop assigned territory and target account plan to create a healthy rolling 4-quarter pipeline that will yield sufficient pipeline opportunities.
• Orchestrate team selling efforts within assigned territory among Value Engineering and Consulting Delivery Services.
• Demonstrable track record for winning new customers and growing business within existing customers in a competitive environment.
• Effectively conducting sales both in person and via phone/web with high-level industry executives.
• Demonstrate in-depth knowledge of Syniti products, accounts, competitors, and industry trends to include knowledge of our key go-to-market functional areas namely Data Migration, Master Data Management, Data Quality, and Data Governance.
• Be proactive in understanding customer needs, the industry vertical, priorities, challenges, constraints, and market trends.
• Leverage executive support for sales strategy, partner leadership engagement, and field escalation resolution.
• Manage sales cycles against the goal of meeting and exceeding quarterly annual sales targets.
• Forecast, manage, and update pipeline activities using .
• Be accountable for accurate forecasting and regular sales performance reviews.
• Attend meetings, trainings, and conferences scheduled individually and for the sales team.
• Travel as required.

WHAT IT TAKES

• Bachelor’s Degree in a Business or Technology discipline would be an advantage.
• Have the legal right to live and work in the US.
• Ideally at least 7+ years of proven direct and/or indirect sales experience; software sales/service preferred (large enterprise customers).
• Experience with Sandler or similar sales methodology, preferred.
• Experience in territory and pipeline management including prospecting, driving, orchestrating, and closing complex sales cycles.
• Demonstrated value and solutions sales experience.
• Contacts with industry decision-makers including customers, Partners (SAP) and System Integrators (IBM, Accenture, Deloitte).
• Goal-oriented, with a track record of overachievement (President’s Club, Rep of the Year, etc.)
• Highly driven, possessing a strong desire to be successful.
• Disciplined and skilled in managing time and resources; sound approach to qualifying opportunities.
• Possesses aptitude to learn quickly and establish credibility.
• Detailed oriented in negotiating contracts and terms.
• Strong work ethic, hands-on style.
• Committed team player with an entrepreneurial spirit.
• Excellent written and verbal communication skills.
• Be fully aligned to our core values:
• Think Big - Be courageous and bold. Aspire to greatness. Relentlessly pursue market innovation. Set the standard by which others follow. Create solutions that have a meaningful impact. Solve the challenges our customers don’t know they have.
• Be Curious - Be a lifelong learner. Seek out new ideas to serve customers. Understand our competition and the world. Be permanently dissatisfied with the status quo. Challenge preconceptions. Focus on the future rather than yesterday.
• Take Action - Be the first. Don’t wait. Take accountability. Inspire others by doing. Fail fast and learn from mistakes. Make a difference every day.
• Stronger Together - Respect, trust and look out for each other. Celebrate diverse perspectives. Listen. Build connections and belonging. Act with integrity. Give back. One Syniti family.

WHAT WE OFFER

• Trust in your talent. At Syniti you will find a supportive environment and access to learning tools, but micromanagement is not our style.
• Growth. We are growing rapidly and steadily solving the biggest challenges enterprise companies are faced with today. There was never a better time to join and grow with us. Most importantly you will have the chance to shape our journey and share in our success story.
• Support. We all rely on each other and enable each other to be successful. You won’t stand alone.
• Curiosity and genuine interest in you. We all have our different stories, all equally fascinating with each depicting a different journey and we want to hear them all.
• Recognition. We are the sum of individual achievements, and we always take the time to celebrate them.
• An open organisation. Titles don’t define access at Syniti. We stay humble regardless of where we sit in the organisation. We want to hear every voice, listen to all the ideas and make sure everyone’s work is seen and valued.

Syniti discloses salary range information in compliance with state and local pay transparency obligations. The disclosed range represents the lowest to highest salary we, in good faith, believe we would pay for this role at the time of this posting, although we may ultimately pay more or less than the disclosed range, and the range may be modified in the future. The disclosed range takes into account the wide range of factors that are considered in making compensation decisions including, but not limited to: relevant education, qualifications, certifications, experience, skills, seniority, performance, sales or revenue-based metrics, and business or organizational needs. At Syniti, it is not typical for an individual to be hired at or near the top of the range for their role. The base salary range for this role is $140,000 - $170,000. This role may be eligible for other compensation including variable compensation, bonus, or commission. Full time regular employees are eligible for paid time off, medical/dental/vision insurance, 401(k), and any other benefits to eligible employees. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, or any other form of compensation that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.

Our Commitment to Inclusion

At Syniti, we’re committed to creating a respectful, inclusive, and fair workplace where everyone belongs and thrives. We believe that diverse perspectives make us stronger — and we value the unique backgrounds, experiences, and voices each person brings to our team.

We welcome applicants based on their skills and potential, and we’re dedicated to ensuring equal opportunities for all, regardless of personal background. If you need accommodations during the hiring process, please let us know — we’re here to support you.

*FULL TIME ROLE

Excited to announce that we're once again working with a global client that is looking to expand it's sales team with a new experienced hire in Boston.

For this position, we're looking for a well-versed individual with proven CAPEX sales experience to the life sciences who can build upon an already existing territory by winning repeat business and new clients in Boston.

Responsibilities

• Manage and maintain client relationships in the life sciences in the Boston area as well as Virginia and Washington.
• Prospect and target potential clients in this territory.
• Manage and deliver a pipeline full of opportunities in the life sciences market.
• Serve as a key point of contact for clients and coordinate with internal stakeholders to manage expectations.
• Identify potential expansion opportunities through market research and client relationships.

Qualifications & Requirements

• Bachelor's degree in relevant markets such as Chemistry and/or Engineering.
• 5+ years of life science experience.
• 5+ years of sales experience in the life sciences.
• Valid US Driver's license.

We Don’t Just Hire Therapists – We Develop Clinical Leaders Who Change Lives

Overview

At POST, every session matters. Our 40-minute, 1:1 treatment model gives you the time and autonomy to deliver truly transformational, evidence-based care (not transactional checklists). With structured mentorship, continuing education investment, and clear professional pathways, we’re committed to developing clinical leaders at every level.

POST Physical Therapy is expanding our high-performing clinical team, and we’re looking for a compassionate, motivated, and growth-minded Physical Therapist talent. If you’re passionate about helping people move better, feel stronger, and return to doing what they love, POST is where you can do your best work.

Our ideal teammate has strong orthopedic skills, delivers exceptional patient care, and thrives in a collaborative, fast-paced, learning-driven environment. You’ll design and deliver individualized care, guide patients through every phase of recovery, and make a measurable impact on their long-term health and performance.

If you’ve ever felt capable of more than your current role allows, POST offers the mentorship, support, and culture to elevate both your clinical career and the lives of your patients.

What You’ll Do

• Deliver 1:1, 40-minute personalized care rooted in evidence-based practice
• Create and progress individualized treatment plans tailored to long-term recovery and performance
• Treat a diverse caseload including orthopedic, post-op, and sport-specific conditions
• Track and celebrate patient progress through detailed assessments and documentation
• Collaborate closely with fellow PTs, support staff, and referring providers for fully integrated care
• Educate, empower, and motivate patients and families inside and outside the clinic
• Contribute to our culture of innovation — including clinical projects, community events, digital content, and team development

What We’re Looking For

• Doctor of Physical Therapy (DPT) or Master’s Degree from an accredited program
• Valid Massachusetts PT license (or ability to obtain)
• Experience in outpatient orthopedics strongly preferred
• Strong clinical foundation in anatomy, physiology, manual therapy, and therapeutic exercise
• Excellent communicator who can motivate, connect, and lead patients through the recovery journey
• Independent, self-driven clinician who thrives in a collaborative, growth-oriented team
• Commitment to contributing to a people-centered, positive, and ambitious clinic culture

Why POST? A Career - Not Just a Job

Clinical Excellence Is Our Standard

Our 40-minute one-on-one model, supported by the most up to date EMR and AI tools, ensures you have the time and bandwidth to deliver truly meaningful, high-quality care.

Clear & Supported Career Pathways

We invest heavily in clinician development with:

• Structured mentorship at all levels
• Continuing education reimbursement
• Leadership tracks (clinical education, team lead, clinic partner roles)
• Opportunities to specialize, teach, mentor, and lead

Whether you see yourself as a future specialist, educator, or partner, we help you grow toward your goals.

Sustainable, Balanced Workload

We believe great clinicians need balance to deliver great care. Our scheduling, productivity expectations, and team workflows are designed to support long-term excellence, not burnout.

A Culture You’ll Want to Be Part Of

POST is built on ownership, curiosity, collaboration, and raising the bar. Every teammate contributes to the outcome, every win feels shared, and everyone is committed to getting better together.

Compensation & Benefits

• Full-time position with flexible scheduling options
• Base Salary Range: $85,000+, commensurate with experience
• Performance-based bonuses
• Health and dental insurance
• 401(k)
• Continuing education reimbursement
• Supportive team culture and high-growth environment

Location

In person – Our home base is located in Brookline, MA

(Additional locations coming soon as POST expands)

How to Apply

Send your resume to with “PT Position” in the subject line.

If you’re ready to grow your career in a place that values excellence, autonomy, and real impact — we’d love to meet you.

Location: Woburn, MA (on-site 5 days per week)

Vaxess is developing a pipeline of next-generation therapeutics on our novel micro-array patch platform. With only five minutes of wear-time on the skin, the Vaxess’ patch combines room temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world.

The Role:

The Quality Engineer I / II will support Quality Assurance activities for Vaxess’ combination product programs, with a strong focus on medical device design controls, risk management, and cGMP compliance. This role provides hands-on quality support across design and development, supplier oversight, process validation readiness, and batch record/data review, aligned with ISO 13485, 21 CFR 820, and applicable combination product regulations (21 CFR 4).

Reporting to the Quality Assurance Manager, this role works cross-functionally with Manufacturing, Process Development, Quality Control, and Material Management to support compliant execution and ensure product quality and safety during early clinical development.

Responsibilities:

• Support quality oversight of Vaxess combination product(s) to ensure compliance with safety, efficacy, and regulatory requirements.
• Administer and support the Quality Management System (QMS) in accordance with ISO 13485, 21 CFR 820, 21 CFR Part 4 (Combination Products), and applicable FDA and international regulations.
• Provide quality support for Design Control activities, including Design History File (DHF) maintenance, design reviews, Design Verification and Validation (DVV), and design changes.
• Support risk management activities, including development and maintenance of risk analyses (e.g., FMEA, hazard analyses) and linkage to design and process controls.
• Support process validation and qualification activities, including test method validation (TMV), process validation (PV), and equipment qualification, as applicable to Phase I and GMP-ready manufacturing.
• Participate in Material Review Board (MRB) activities, including nonconformance assessment, disposition, and documentation.
• Perform quality review and approval of batch records, executed manufacturing records, analytical data collection forms, test records, and technical or experimental reports.
• Collaborate in supplier quality management activities, including supplier qualification, auditing, monitoring, change evaluation, and periodic requalification.
• Author, review, and revise quality documentation, including SOPs, work instructions, test methods, protocols, reports, forms, and specifications.
• Support preparation, review, and organization of quality data and documentation for regulatory submissions and inspections.
• Contribute to continuous improvement initiatives within the QMS, including CAPA, deviation investigations, and quality metrics.

Qualifications:

• Quality Engineer I: Minimum of 3 years of experience in Quality Assurance or Quality Engineering within a cGMP-regulated medical device or combination product environment.
• Quality Engineer II: Typically 4–5 years of progressive quality experience in medical devices, pharmaceuticals, biologics, or combination products.
• Working knowledge of ISO 13485 and FDA medical device Quality System Regulations (21 CFR 820); familiarity with combination product requirements strongly preferred.
• Experience supporting early-phase (preclinical to Phase I) product development is highly desirable.
• Experience with design controls, risk management (FMEA), and validation activities preferred.
• Experience reviewing GMP documentation such as batch records, test methods, protocols, and reports.
• Strong written and verbal communication skills, with the ability to clearly document technical and quality concepts.
• Proficiency with Microsoft Office applications (Word, Excel, PowerPoint).

At Vaxess, we’re bringing together exceptional talent to drive our product development forward. We value collaboration, curiosity, and a dynamic work environment. To apply, please submit your CV/resume to

Optomi, in partnership with a leading provider in the Healthcare industry is seeking an AI Risk & Compliance Analyst to join their team. You will be responsible for performing compliance reviews of AI applications to ensure alignment with internal policies and governance standards. The role involves conducting structured risk assessments across the AI system lifecycle, identifying risks related to bias, privacy, security, and regulatory noncompliance. The analyst will work collaboratively with AI development teams to gather information for assessments and prepare clear findings and recommendations for leadership.

Key duties and responsibilities:

• Performs compliance reviews of AI applications and products to assess alignment with internal policies, governance standards, and standard operating procedures, including verification of required documentation, approvals, and controls prior to production deployment.
• Conducts structured risk assessments of AI systems across their lifecycle, identifying and documenting risks related to bias, privacy, security, safety, model behavior, and regulatory noncompliance; evaluate risk likelihood, impact, and adequacy of mitigation controls.
• Reviews model development practices, data handling procedures, deployment controls, and technical artifacts (e.g., model cards, system architecture documentation) to identify compliance gaps and discrepancies between documented capabilities and actual system behavior.
• Investigates AI system incidents, complaints, or governance concerns by analyzing system behavior, data flows, and decision logic; document investigative methods, evidence reviewed, and conclusions reached.
• Conducts hands on testing and probing of AI systems to validate documented claims regarding performance and behavior, and support ongoing monitoring of deployed systems.
• Tracks compliance and risk findings, remediation actions, and residual risk through maintained risk registers and supporting documentation; verify corrective actions are implemented and documented.
• Partners with AI development teams, product owners, and subject matter experts to gather information for assessments and investigations, and prepare clear findings, executive summaries, and recommendations for leadership and governance stakeholders.
• Monitors trends in compliance and risk findings to identify systemic issues and support continuous improvement of AI governance practices; stay current with evolving AI regulations, standards, and industry best practices.