Design Quality Engineer
Katalyst Healthcares and Life Sciences
Summary:
- The Quality Engineering Project Manager provides leadership, direction, and technical oversight for the Quality Engineering team within Operations.
- This role leads quality engineers who support manufacturing processes and provide quality engineering expertise for product, process, equipment, utility, and facility-related activities.
- The position ensures effective implementation of Client Quality Systems and supports validation, qualification, and risk-based compliance decisions across base business and development or market expansion initiatives.
- The Quality Engineering Project Manager also manages functional resources and budget while maintaining strong quality, compliance, and operational performance.
- Leads and develops a team of quality engineers supporting manufacturing process quality oversight, validation, qualification, and compliance activities.
- Provides functional leadership for quality engineering activities across manufacturing processes, equipment, utilities, facilities, and associated systems.
- Provides technical direction for quality engineering matters related to base business operations, development, tech transfer, and market expansion projects.
- Ensures validation and qualification strategies, protocols, reports, and lifecycle activities are executed in accordance with Client Quality Systems, cGMP requirements, and applicable regulations.
- Reviews quality and compliance gaps related to manufacturing processes, equipment, utilities, systems, and change controls, and drives appropriate risk-based actions.
- Partners with Manufacturing, Validation, Engineering, Regulatory, Quality Systems, and Development to support compliant implementation of new and existing processes.
- Guides risk management activities, including assessments, mitigation planning, and application of quality risk management principles.
- Oversees or supports qualification and validation activities for equipment, processes, cleaning, utilities, computerized systems, and methods, as applicable.
- Ensures quality engineering issues impacting product quality, process robustness, and regulatory compliance are identified, escalated, and resolved.
- Communicates quality engineering status, key risks, trends, and recommendations to management and executive stakeholders, and manages functional resources and budget to support efficient execution.
- Minimum Bachelor's Degree required preferably in Physical or Life Sciences, Pharmacy, or Engineering.
- Certified Quality Engineer or formal training in quality engineering or statistics is preferred.
- 8+ years of combined experience in Manufacturing, QA, QC, R&D in pharmaceutical, biologics, device or chemical industry.
- 4+ years of supervisory/technical leadership experience.
- Must have a basic understanding and working knowledge of the physical and chemical characteristics of the products, including raw materials, manufactured at the plant.
- Must be familiar with use of statistical quality systems, electronic document management and laboratory information management.
- Must also be familiar with Quality policies as well as cGMP and other regulatory requirements.
- Must have effective people management and communication skills necessary to supervise those reporting directly or through subordinates as well as establish and maintain effective working relationships among other key individuals in manufacturing, materials management, engineering, product development, Quality Systems, Product QA, Quality Control, Information Systems and Regulatory Affairs and must demonstrate sound judgment in evaluating and acting on day-to-day situations.
- Strong communication Skills, both oral and written.
- Bachelor's, Master's or PhD in a Life Science or Engineering is Highly Desired.
- Demonstrated strategic vision and leadership in building and sustaining a high-performing team responsible for managing base business priorities, site-related projects, compliance remediation activities, and global project deliverables is Highly Desired.
- Strong cross-functional collaboration and negotiation skills, with the ability to influence stakeholders, align priorities, and drive effective outcomes across complex and diverse functional teams is Highly Desired.
Vacancy posted 5 days ago
Similar jobs that could be interesting for youBased on the Design Quality Engineer in Cambridge, MA vacancy
- Job Description: The Design Quality Engineer will support the Lifecycle Management organization responsible for maintaining existing medical device products across sports medicine and soft tissue repair. This individual will work cross-functionally with product design engineering...Suggested
- ...Job Description: Responsible for ensuring compliance to design controls, risk management, and verification/validation activities... ...understanding of: Design controls & product lifecycle Systems engineering Experience in: DFMEA / risk analysis Requirement...Suggested
- Job Description: The Design Quality Engineer (DQE) at Philips is responsible for ensuring that products are designed and developed in compliance with regulatory standards, quality requirements, and customer expectations. This role works closely with R&D, regulatory, manufacturing...Suggested
$134k - $186k
Job TitleSenior Manager - Design Quality EngineeringJob DescriptionDesign Quality ManagerIn this role you Will Lead a team of Design Quality Engineers in providing guidance to project teams both as a manager and as a Subject Matter Expert to Core Teams regarding Design...SuggestedFull timeWork at officeImmediate startRemote workWork visaRelocation package3 days per week$102k - $163k
JOB DESCRIPTION Job Title Software Design Assurance Quality Engineer Job Description The Software Design Assurance Quality Engineer is responsible for ensuring top-level design quality assurance for the creation, modification, maintenance of cloud based...SuggestedFull timeWork at officeImmediate startWork visaRelocation package3 days per week$82.3k - $220k
...defense and space exploration to biomedical engineering, lives often depend on the solutions we... ...Summary:As a Senior Component Quality Engineer, you will be responsible for the... ...stakeholders including but not limited to designers, component engineers, procurement agencies...Full timeLocal area- ...The Plant Quality Engineer (PQE) - Responsible for all aspects of product conformity for their systems / Components at the Warren Truck Assembly... ...Lead teams to identify issues/risks associated with product designs, processes and applications by utilizing FMEA’s and other...Hourly payFull timeImmediate start
Stellantis
Cambridge, MA1 day ago $75k - $156k
...defense and space exploration to biomedical engineering, lives often depend on the solutions we... ...effects on overall system performance.Design harden and verify the performance of... ...independently execute assignments.Contribute high quality content for technical reports and...Full timeLocal area$150k - $250k
Job Title: Sr. Power Circuit Design Engineer - GaN/SiCLocation: Somerville, MACompensation: $150K - $250K DOERequirement: MS or PhD w/ 5+ years of power circuit design, wide bandgap power devices (GaN HEMTs or SiC MOSFETs)Position OverviewWe are seeking a highly skilled...$146k - $194k
...defense industry, Anduril is changing how military systems are designed, built and sold. Anduril’s family of systems is powered by... ...to the military in months, not years.ABOUT THE TEAM:Our Quality Engineering team is a dedicated group of professionals committed to ensuring...Full timeWork experience placementImmediate startRelocation- Quality Test Engineer (QTE) Contractor. $55 to 85/hr w2 or 1099 This is a hybrid work environment opportunity located in Boston, Massachusetts... ...reviewing, and refining work products (requirements specifications, design documentation, user stories and models) to ensure...For contractorsWork experience placementWork at officeRemote workMonday to Friday
- Quality Test Engineer (QTE) Contractor, CRD Financial Services Testing,Boston, MA. Hybrid, up to $85 HR W2Our client is seeking a Quality Test... ...reviewing, and refining work products (requirements specifications, design documentation, user stories and models) to ensure...For contractorsWork experience placementLocal area
$82.3k - $220k
...solutions. From military defense and space exploration to biomedical engineering, lives often depend on the solutions we provide. Our... ...tackle challenging engineering problems in advanced digital IC design. As a Senior Digital ASIC Designer, you will be responsible for...Full timeLocal area$130k - $190k
...including Apple, Google, Tesla, New Balance, and NASA. Together, we’re helping everyone design, prototype, and manufacture faster than ever before.We’re a team of hands-on builders, engineers, and innovators reinventing how the world makes physical things. If you’re ready to...Full timeWork at officeWorldwideFlexible hours$150k - $250k
Job Title: Senior ASIC Design EngineerJob Location: Santa Clara, CA or Boston, MACompensation... ...a highly skilled Senior ASIC Design Engineer to lead the design and development of advanced... ...and validation of designs to ensure high-quality outputs and compliance with standards....- ...everyone can thrive.Why join the Harvard John A. Paulson School of Engineering and Applied Sciences?At the Harvard John A. Paulson School of... ...Through teaching and collaborative research, SEAS discovers, designs, and creates novel technologies and approaches to societal...Monday to FridayFlexible hoursWeekend work
$92.2k - $141.4k
About Us SharkNinja is a global product design and technology company, with a diversified... ...in.The Senior Product Safety & Compliance Engineer will have a direct partnership with our... ...Management for Medical DevicesISO 13485 - Quality Management SystemsIEC 62366-1 - Usability...Temporary workLocal areaFlexible hoursShift work- ...To accelerate this project, the Software Engineer will develop an automated machine learning... ....PRINCIPAL DUTIES AND RESPONSIBILITIES:• Design and develop mechanical systems,... ...projects.Able to perform and incorporate quality work within technical specifications.Can...Temporary workWork at office
- ...HOK Group, Inc. in Boston seeks a Senior Design Professional to coordinate design development and project delivery in our Transportation practice. This role involves analyzing architectural documents, developing presentations, and mentoring junior staff while fostering...
HOK Group, Inc.
Boston, MA5 days ago - ...re passionate about taking on unsolved challenges, we have a great opportunity for a results-oriented and highly motivated RTL Design Engineer. Are you looking to expand your chip design career and challenge yourself in a technical and multi-disciplinary endeavor? If so...
Apple
Watertown, MA3 days ago - ...global leader in audio visual and media innovation, recognized for designing and building the world's most experiential environments. Our... .... How You'll Contribute: The Senior Design Engineer (SDE) is a lead member of the core team for each Workplace (WKP...Temporary workLocal areaRemote workRelocationHome officeFlexible hours
Diversified
South Boston, MA3 days ago $82.3k - $220k
...defense and space exploration to biomedical engineering, lives often depend on the solutions we... .... The candidate will be responsible for designing and implementing design transfers of... ...Assembly, Test, Manufacturing, Reliability, Quality, Cost, Sustainability, Supply Chain,...Full timeLocal area- ...looking for a passionate Systems QA Test Engineer to join our QA team within our Engineering... ...test protocols to ensure that the design outputs (actual product- system’s functionality... ...data from testing activities to measure the quality of the product. Identify tools, fixtures,...Full time
Pickle Robot Company
Charlestown, MA1 day ago $103k - $163k
JOB DESCRIPTION Job Title Design Quality Engineer Job Description The Design Quality Engineer is accountable for design quality, risk management, sustaining and complaint investigations for Philips Image Guided Therapy products. Your role: Ensures...Full timeWork at officeImmediate startWork visaRelocation package3 days per week- ...? We have an opportunity for an outstandingly hardworking design verification engineer! As a member of our wide-ranging group, you will have the... ...technologies to achieve efficient execution and improved quality. **Minimum Qualifications** + Minimum requirement of a bachelors...Work experience placement
Apple
Watertown, MA1 day ago $96k - $120k
...We are looking to hire a QA Automation Engineer II to join our Enterprise Applications... ...role, you will play a critical part in designing, building, maintaining, and improving automated... ...of the role is experience with software quality, including the ability to create end-to...Flexible hours- ...detail? As part of our Silicon Technologies group, you’ll help design and manufacture our next-generation, high-performance, power-efficient... ...they love with their devices. The DFT Design Verification Engineer will be on a team which is responsible for the complete DFT pre...
Apple
Watertown, MA5 days ago $82.3k - $220k
...solutions. From military defense and space exploration to biomedical engineering, lives often depend on the solutions we provide. Our... ...about Draper, visit .Job Description Summary:The IC Packaging Design & Layout Engineer is responsible for the end to end creation of...Full timeLocal area$120k - $160k
...class service across the biopharmaceutical and clinical markets. Job Summary: Nova Biomedical is seeking a Principal Design Quality Engineer I to support the development of innovative, high-performance diagnostic and analytical technologies used in clinical care,...Hourly payWork at officeFlexible hours$105.4k - $207.8k
Position Summary Senior QA Engineer -AI & EngineeringJoin our AI & Engineering team... ...Engineering as a Service provides complete design, implementation, and technology... ...industry role.4+ years’ experience driving the quality assurance processes and gaining delivery...Local areaVisa sponsorshipFlexible hours
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Design Quality Engineer. Be the first to apply!
Related searches
- data center design engineer Cambridge, MA
- design engineer Cambridge, MA
- product design engineer Cambridge, MA
- senior manager product engineering Cambridge, MA
- senior software design engineer Cambridge, MA
- product engineer Cambridge, MA
- supplier quality engineer Cambridge, MA
- customer quality engineer Cambridge, MA
- senior data quality engineer Cambridge, MA
- program quality engineer Cambridge, MA