Current jobs related to Senior Product Quality Assurance Engineer - Cambridge, Massachusetts - Draper Labs

  • Senior Quality Assurance Specialist

    3 weeks ago

    Cambridge, Massachusetts, United States Proclinical Staffing Full time

    Job Title: Incoming Materials, Senior QA SpecialistProclinical is seeking an experienced Incoming Materials, Senior QA Specialist to join our team in Cambridge, MA.Job Summary:The Incoming Materials, Senior QA Specialist will play a critical role in ensuring the quality and compliance of materials procured by our organization. This position requires a strong...

  • Senior System Quality Assurance Engineer

    1 month ago

    Cambridge, Massachusetts, United States Draper Labs Full time

    Job DescriptionDraper is a leading research and development company that tackles important national challenges with a promise of delivering successful and usable solutions. As a Senior System Quality Engineer, you will play a critical role in ensuring that products meet the highest quality standards.Key ResponsibilitiesInvestigate and resolve issues related...

  • Senior Manager of Quality Assurance

    3 weeks ago

    Cambridge, Massachusetts, United States eGenesis Bio Full time

    Job Title: Senior Manager, Quality Assurance Job Summary: At eGenesis Bio, we are seeking a highly skilled Senior Manager, Quality Assurance to oversee our GMP cloning operations and Supplier Management Program. This is a critical role that requires strong leadership, technical expertise, and excellent communication skills. Key Responsibilities: *...

  • Senior Manager of Quality Assurance

    3 weeks ago

    Cambridge, Massachusetts, United States eGenesis Bio Full time

    Job Title: Senior Manager, Quality AssuranceAt eGenesis Bio, we are seeking a highly skilled and experienced Senior Manager, Quality Assurance to join our team. This is a critical role that will oversee the GMP cloning operations and Supplier Management Program to ensure compliance with regulatory requirements.Key Responsibilities:Develop, implement, and...

  • Quality Assurance Manager

    3 weeks ago

    Cambridge, Massachusetts, United States HyperLight Full time

    Quality Lead Job DescriptionHyperLight is a venture-backed startup that has revolutionized the field of photonics with its innovative photonic integrated circuits. We are seeking a highly experienced and effective Quality Lead to join our team and play a crucial role in taking our PIC production and delivery to the next level.Key Responsibilities:Design,...

  • Senior Manager of Quality Assurance

    1 month ago

    Cambridge, Massachusetts, United States eGenesis Bio Full time

    Job Title: Senior Manager, Quality AssuranceeGenesis Bio is seeking a highly skilled Senior Manager, Quality Assurance to oversee the GMP cloning operations and Supplier Management Program. This role will be responsible for ensuring compliance to GMP standards of vendors that are part of the Supplier Management Program.Key Responsibilities:Developing,...

  • Senior Director of Quality Assurance

    2 weeks ago

    Cambridge, Massachusetts, United States Jobot Full time

    Job Title: Senior Director, Quality AssurancePublicly Traded + Equity + Annual Bonus + HybridWe are a publicly traded biotechnology company developing biologics to treat chronic dermatological diseases.Why Choose Us?Competitive SalaryAnnual BonusEquityESPP401k ProgramMedical/Vision/DentalHybrid ScheduleJob Description:We are seeking a Senior Director of...

  • Senior Director, Quality Assurance

    2 weeks ago

    Cambridge, Massachusetts, United States Beam Therapeutics Inc. Full time

    Job Title: Senior Director, Quality ControlBeam Therapeutics Inc. is seeking a highly experienced Senior Director, Quality Control to join our team in Cambridge, Massachusetts. As a key member of our Quality Control organization, you will be responsible for leading the quality control organization at our Massachusetts facility and providing strategic...

  • Senior Director of Quality Assurance

    2 weeks ago

    Cambridge, Massachusetts, United States Jobot Full time

    Job SummaryWe are seeking a highly experienced Senior Director of Quality Assurance to provide quality oversight of our clinical development programs and manufacturing. As a key member of our team, you will be responsible for ensuring the highest standards of quality and compliance in our GMP suppliers.Key Responsibilities* Provide quality support and...

  • Quality Assurance Specialist

    1 week ago

    Cambridge, Massachusetts, United States Draper Labs Full time

    Job Description:Draper Labs is seeking a Quality Assurance Specialist to join our Quality Audit team. As a Quality Assurance Specialist, you will be responsible for conducting process and product compliance audits related to Draper's Quality Management System (QMS) based on ISO 9001:2015 and AS9100 standards.Key Responsibilities:• Conduct process and...

  • Senior Quality Assurance Specialist

    1 week ago

    Cambridge, Massachusetts, United States PSG Global Solutions Careers Full time

    Apply now and our proprietary system will quickly have you in front of a live recruiter. The Opportunity Description We're looking for a Senior Quality Assurance Specialist, working in the Pharmaceuticals and Medical Products industry. Collaborating with raw material vendors, internal quality control, process and analytical sciences, manufacturing, and...

  • Senior Quality Assurance Specialist

    3 weeks ago

    Cambridge, Massachusetts, United States PSG Global Solutions Careers Full time

    The OpportunityWe're seeking a highly skilled Senior Quality Control Associate to join our team in the Pharmaceuticals and Medical Products industry.Collaborate with vendors, internal quality control, process sciences, manufacturing, and quality assurance departments to ensure raw material specifications meet company and regulatory expectations.Develop and...

  • Senior Quality Assurance Manager

    1 week ago

    Cambridge, Massachusetts, United States Draper Labs Full time

    Job SummaryDraper Labs is seeking a highly skilled Senior Quality Assurance Manager to lead our Supplier Quality Group. As a key member of our team, you will be responsible for ensuring the quality of our suppliers and developing strategies to improve our supply chain.Key ResponsibilitiesLead a team of quality assurance professionals to ensure compliance...

  • Senior Director of Quality Assurance

    1 week ago

    Cambridge, Massachusetts, United States Jobot Full time

    Publicly Traded Biotechnology Company seeks a Senior Director of Quality Assurance to provide quality oversight of our clinical development programs and manufacturing. This is a hybrid position requiring 3 days per week on site. Responsibilities include:Providing quality support and guidance for our CMC programsPlanning, conducting, or facilitating supplier...

  • Senior Director of Quality Assurance

    2 weeks ago

    Cambridge, Massachusetts, United States Jobot Full time

    Job DescriptionWe are a publicly traded biotechnology company developing biologics to treat chronic dermatological diseases.As a Senior Director of Quality Assurance, you will provide quality oversight of our clinical development programs and manufacturing.Responsibilities:Provide quality support and guidance for our CMC programsPlan, conduct or facilitate...

  • Principal Combination Product Quality Engineer

    3 weeks ago

    Cambridge, Massachusetts, United States Alnylam Full time

    Job Title: Principal Combination Product Quality EngineerThis is a hybrid role that requires a strong understanding of quality assurance principles and practices in the development and manufacturing of combination products.Key Responsibilities:Lead quality oversight and provide QA strategy for combination product design and development programs.Provide...

  • Principal Combination Product Quality Assurance Specialist

    1 week ago

    Cambridge, Massachusetts, United States Alnylam Full time

    The Principal Combination Product Quality Assurance Specialist will provide QA support to Combination Product Design and Development, Design Transfer, and on-market support.This role will work cooperatively with their counterparts throughout Technical Operations and Quality to ensure safe and effective combination products are developed, brought to market,...

  • Quality Assurance Manager

    3 weeks ago

    Cambridge, Massachusetts, United States Vericel Corporation Full time

    Job Title: Quality Assurance ManagerVericel Corporation is seeking a highly skilled Quality Assurance Manager to join our team. As a key member of our quality team, you will be responsible for ensuring the quality of our products and processes.Key Responsibilities:Develop and implement quality systems and procedures to ensure compliance with regulatory...

  • Senior Director of Quality Assurance

    3 weeks ago

    Cambridge, Massachusetts, United States Jobot Full time

    Job OverviewWe are seeking a seasoned Senior Director of Quality Assurance to provide strategic quality oversight of our clinical development programs and manufacturing operations.This is a hybrid position requiring 3 days per week on-site at our facility.Key ResponsibilitiesProvide quality support and guidance for our CMC programsPlan, conduct, or...

  • Senior Director of Quality Assurance

    1 week ago

    Cambridge, Massachusetts, United States Jobot Full time

    Job Summary:We are seeking a highly experienced Senior Director of Quality Assurance to provide quality oversight of our clinical development programs and manufacturing. The ideal candidate will have a strong background in biologics, specifically operational QA experience with monoclonal antibodies, and expertise in partnering with external manufacturers.Key...

Senior Product Quality Assurance Engineer

2 months ago

Cambridge, Massachusetts, United States Draper Labs Full time

Job Summary:

The Senior Product Quality Assurance Engineer is responsible for partnering with cross-functional teams to develop and implement quality assurance plans, procedures, and processes to meet customer and regulatory requirements. This role requires a strong understanding of quality management systems, including ISO 9001:2015 and AS9100.

Key Responsibilities:

  • Develop and implement quality assurance plans, procedures, and processes to meet customer and regulatory requirements.
  • Partner with cross-functional teams to review and interpret requirements, develop Mission Assurance plans, and prepare plans and requirements documents.
  • Interact with customers and cross-functional teams to prepare plans and requirements documents based on Draper's established Quality Management System (QMS) guidelines.
  • Work independently with program and engineering cross-functional teams to assist with implementation of best engineering practices and processes.
  • Provide engineering solutions to focus on program execution, overall design, and product quality.
  • Identify and manage risks/opportunities, participate in reviews of design plans, process procedures, test procedures, and quality requirements.
  • Review, interpret, and revise electrical and mechanical parts specifications, along with circuit card assemblies.
  • Prepare MRB documentation and reviewing and authorizing product or process deviations with customer or internal program approval.
  • Utilize analytical skill sets to perform Root Cause, Causal Analysis, and Corrective/Preventive Action.
  • Analyze data to identify trends in product quality or defects with a goal of mitigating and preventing recurrence and future defects.
  • Responsible for handling, storage, marking, packaging, and preservation and delivery of products.
  • Provide QMS guidance and direction to program personnel for QMS compliance.
  • Manage and oversee program document peer reviews, submittal, and approval for product's Configuration Management release.
  • Excellent communication, interpersonal, and leadership skills with programs and engineering groups throughout the organization.
  • Support program internal and external audits and supplier surveillance activities when necessary.

Requirements:

  • Bachelor of Science degree in an engineering discipline.
  • 5-7 years of experience in quality engineering or other engineering role.
  • Working knowledge of Lean Six Sigma principles.
  • Familiarity with Quality Standards ISO 9001:2015 and AS9100.
  • Expert knowledge and skills in process integration.
  • Strong organizational skills and attention to detail.
  • Excellent time management skills with the proven ability to meet deadlines.
  • Ability to prioritize tasks.
  • Strong analytical and problem-solving skills.
  • Good interpersonal skills to communicate clearly.
  • Excellent written and oral communication skills.