Senior Quality Engineer

3 days ago

Philadelphia, United States PCI Pharma Services Full time

The Senior Quality Engineer (Sr. QE) - New Product Introduction (NPI) is a pivotal customer-facing role at the Philadelphia Site. This position is responsible for onboarding and supporting new customer programs, transitioning products and processes from engineering to manufacturing and the supply chain. The Sr. QE collaborates closely with product engineering to define manufacturing requirements throughout the New Product Development process, encompassing all phases of Design for Assembly (DFA) and Design for Manufacturing (DFM). The Sr. QE provides leadership by mentoring and coaching junior Quality Engineers, establishing training programs, and ensuring adherence to quality standards. Acting as the primary contact for customer programs, the Sr. QE provides technical support during project milestones, manages scope changes, handles internal and external escalations and ensures compliance with global standards for strategic accounts.


ESSENTIAL DUTIES AND RESPONSIBILITIES:


Leadership

• Mentor and coach junior Quality Engineers in NPI and commercial areas.

• Establish and deliver training programs on QE principles, cGMPs, product, and process familiarity.

• Collaborate with engineering, business development, and cross-functional teams in development, manufacturing, and procurement.

• Ensure high standards of work, effective time management, and data-driven problem-solving.

• Present quality standards, process flows, and inspection plans confidently and accurately, both internally and externally.


Technical (Product and Process)

• Lead new customer programs through the development lifecycle, promoting best engineering practices.

• Develop and implement workflows and sampling plans for OQ/PQ activities.

• Analyze manufacturing data, conduct root cause analysis of deviations/complaints, and support design/manufacturing concept selection.

• Create and maintain work standards to ensure projects are delivered on time, within scope, and budget.

• Interpret product requirements and ensure compliance with quality system procedures and industry standards.

• Develop Master Batch Records, work instructions, and related manufacturing and packaging documentation.

• Support the generation of Measurement System Analysis, Control Plans, Process Flow Maps, Inspection plans, GR&R, and test requirements.

• Maintain process discipline to meet project deliverables, including manufacturing strategy, capability analysis, FMEA, tooling selection, risk management, cost modeling, Design for Manufacturing, and process validation.

• Review and develop technical specifications and use data-driven tools for problem-solving.

• Identify opportunities for product and process improvements and develop recommendations.


Supplier Quality

• Participate in External Audits of Suppliers/Contract Service Providers.

• Manage internal and external suppliers required to support product design tasks.


QUALIFICATIONS


Required:

• College Degree required (engineering degree or related scientific degree). Must have a minimum of at least five years of experience in an FDA regulated industry with strong preference to medical device or

combination products.

• Demonstrated proficiency with personal computers, business software (e.g., MS Office) and technical

software (ERP and eQMS systems). Ability to create, use and interpret scientific tables, charts, and graphs.

• Advanced Computer Skills: Ability to perform the most complex computer tasks and operate various

computer programs.

• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels

pertinent to professional needs.

• Analytical ability to drive effective Root Cause Analysis (RCA) and critical thinking for complex problem

solving.


Preferred:

• Possesses excellent organizational, time management and multi-tasking skills to meet commitments and

deadlines.

• Prior experience in technical writing and utilizing root cause analysis tools is required.

• Critical thinking skills along with a strong collaborative approach are required.

• Lean Six Sigma or other formal process improvement skillsets are highly desirable.

• Technical knowledge and experience around Test Method Validation, Medical Devices, and Sterilization

processes is preferred.


Soft Skills

• Excellent communication skills, both written and verbal, with the ability to effectively present complex

information to diverse audiences.

• Strong leadership and mentoring abilities, with a track record of developing team members.

• Adaptability and resilience in a fast-paced, evolving environment.

• Exceptional problem-solving skills with a proactive approach to identifying and addressing issues.

• Demonstrated ability to build and maintain strong relationships with internal and external stakeholders.

• High emotional intelligence and empathy, for effective team collaboration and customer interactions.

  • Senior Quality Assurance Engineer

    2 months ago

    Philadelphia, United States Meet Full time

    Join our exciting growing Biotech client - they are hiring a QA Engineering Specialist/Senior level to join their team!Position Title: Quality Assurance Engineering SpecialistDepartment: Quality AssuranceLocation: Onsite Manufacturing Site, Philadelphia, PAShift: 3-11:30pm ESTReports To: Quality Assurance ManagerJob Summary:As a Quality Assurance Engineering...

  • Senior Quality Assurance Engineer

    1 month ago

    philadelphia, United States Meet Full time

    Join our exciting growing Biotech client - they are hiring a QA Engineering Specialist/Senior level to join their team!Position Title: Quality Assurance Engineering SpecialistDepartment: Quality AssuranceLocation: Onsite Manufacturing Site, Philadelphia, PAShift: 3-11:30pm ESTReports To: Quality Assurance ManagerJob Summary:As a Quality Assurance Engineering...

  • Senior Quality Assurance Engineer

    4 weeks ago

    Philadelphia, Pennsylvania, United States Catalent Inc Full time

    About the Role:Catalent Inc is seeking a Senior Quality Assurance Engineer to join our team in Philadelphia. As a Senior Quality Assurance Engineer, you will be responsible for providing Quality Assurance guidance and support for activities related to Manufacturing and Packaging operations at Catalent Philadelphia.Key Responsibilities:Supports regulatory...

  • Senior Project Engineer

    4 weeks ago

    Philadelphia, Pennsylvania, United States HNTB Full time

    Job Title: Senior Project EngineerAbout the Role:We are seeking a highly skilled Senior Project Engineer to join our team at HNTB. As a Senior Project Engineer, you will be responsible for leading complex engineering projects from conception to completion. You will work closely with our project managers to ensure that projects are delivered on time, within...

  • Senior Mechanical Engineer

    4 weeks ago

    Philadelphia, Pennsylvania, United States Westinghouse Electric Company Full time

    Job Summary:We are seeking a highly skilled Senior Mechanical Engineer to join our team at Westinghouse Electric Company. As a key member of our engineering team, you will be responsible for performing engineering calculations in support of subsequent license renewal projects.Key Responsibilities:Performing engineering calculations and analyses to support...

  • Senior Electrical Engineer

    2 months ago

    Philadelphia, United States The Judge Group Full time

    Sr Electrical EngineerHand on engineer Both design and manufacturing aspectsSalary ranging from 85k to 125KSummaryWe are seeking a highly skilled and experienced Senior Electrical Engineer to join our dynamic team. The ideal candidate will be a creative problem-solver with a strong foundation in electrical engineering principles and a proven track record of...

  • Senior Quality Assurance Specialist

    4 weeks ago

    Philadelphia, Pennsylvania, United States Meet Full time

    Job Title: Senior Quality Assurance SpecialistJob Summary:We are seeking a highly skilled Senior Quality Assurance Specialist to join our team. As a key member of our quality assurance team, you will play a critical role in ensuring the quality and compliance of our products throughout the development and manufacturing processes.Key Responsibilities:Quality...

  • Senior Quality Assurance Specialist

    4 weeks ago

    Philadelphia, Pennsylvania, United States Marshwinds International Incorporated Full time

    Job Title: Senior Quality Assurance SpecialistJob Summary: We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Marshwinds International Incorporated. The ideal candidate will have a strong background in both manual and automated testing, with a focus on ensuring the quality and reliability of our software products.Key...

  • Senior Mechanical Project Engineer

    4 weeks ago

    Philadelphia, Pennsylvania, United States Synerfac Full time

    At Synerfac, we are seeking a highly skilled Senior Mechanical Project Engineer to join our team in Philadelphia. This role will play a critical part in providing mechanical engineering expertise across various single and multi-disciplinary design projects within our core market sectors.The ideal candidate will have a solid foundation in HVAC system design...

  • Senior Electrical Engineer

    3 weeks ago

    Philadelphia, United States Hiring Now! Full time

    Sr Electrical EngineerHand on engineer Both design and manufacturing aspectsSalary ranging from 85k to 125KSummaryWe are seeking a highly skilled and experienced Senior Electrical Engineer to join our dynamic team. The ideal candidate will be a creative problem-solver with a strong foundation in electrical engineering principles and a proven track record of...

  • Senior Electrical Engineer

    3 weeks ago

    Philadelphia, United States Hiring Now! Full time

    Sr Electrical EngineerHand on engineer Both design and manufacturing aspectsSalary ranging from 85k to 125KSummaryWe are seeking a highly skilled and experienced Senior Electrical Engineer to join our dynamic team. The ideal candidate will be a creative problem-solver with a strong foundation in electrical engineering principles and a proven track record of...

  • Senior Electrical Engineer

    3 weeks ago

    Philadelphia, United States LVI Associates Full time

    This well established firm is looking to bring on a highly skilled and experienced Senior Electrical Engineer to join our team!Duties & Responsibilities Lead the design and development of electrical systems for various projects, including healthcare, education, senior living facilities, and multi-family and mixed-use complexes. Utilize your expertise to...

  • Senior Electrical Engineer

    3 weeks ago

    Philadelphia, United States LVI Associates Full time

    This well established firm is looking to bring on a highly skilled and experienced Senior Electrical Engineer to join our team!Duties & Responsibilities Lead the design and development of electrical systems for various projects, including healthcare, education, senior living facilities, and multi-family and mixed-use complexes. Utilize your expertise to...

  • Senior Electrical Engineer

    1 month ago

    Philadelphia, United States LVI Associates Full time

    This well established firm is looking to bring on a highly skilled and experienced Senior Electrical Engineer to join their team!Duties & ResponsibilitiesLead the design and development of electrical systems for various projects, including healthcare, education, senior living facilities, and multi-family and mixed-use complexes.Utilize your expertise to...

  • Senior Electrical Engineer

    4 weeks ago

    philadelphia, United States LVI Associates Full time

    This well established firm is looking to bring on a highly skilled and experienced Senior Electrical Engineer to join their team!Duties & ResponsibilitiesLead the design and development of electrical systems for various projects, including healthcare, education, senior living facilities, and multi-family and mixed-use complexes.Utilize your expertise to...

  • Senior Electrical Engineer

    1 month ago

    philadelphia, United States LVI Associates Full time

    This well established firm is looking to bring on a highly skilled and experienced Senior Electrical Engineer to join their team!Duties & ResponsibilitiesLead the design and development of electrical systems for various projects, including healthcare, education, senior living facilities, and multi-family and mixed-use complexes.Utilize your expertise to...

  • Senior Structural Engineer

    3 weeks ago

    Philadelphia, United States StructureCare® Full time

    Are you a Senior Structural Engineer with expertise in forensic investigation, concrete construction, or structural restoration who would like the opportunity to have a mix of office and field engagement that leads to direct involvement with construction and repairs in your next role? Are you passionate about sharing your knowledge and experience through...

  • Senior Structural Engineer

    3 weeks ago

    philadelphia, United States StructureCare® Full time

    Are you a Senior Structural Engineer with expertise in forensic investigation, concrete construction, or structural restoration who would like the opportunity to have a mix of office and field engagement that leads to direct involvement with construction and repairs in your next role? Are you passionate about sharing your knowledge and experience through...

  • Senior Structural Engineer

    2 months ago

    philadelphia, United States StructureCare® Full time

    StructureCare is searching for a Senior Structural Engineer to join the Pennsylvania team! The Senior Structural Engineer will survey and evaluate existing structures and prepare the associated inspection reports. They will communicate the assessment results and follow up plans with business development co-workers and clients. The Senior Structural Engineer...

  • Senior Structural Engineer

    3 months ago

    Philadelphia, United States StructureCare® Full time

    StructureCare is searching for a Senior Structural Engineer to join the Pennsylvania team! The Senior Structural Engineer will survey and evaluate existing structures and prepare the associated inspection reports. They will communicate the assessment results and follow up plans with business development co-workers and clients. The Senior Structural Engineer...