Senior Quality Engineering Manager

3 weeks ago

Rockford, Illinois, United States PCI Pharma Services Full time
Job Summary

We are seeking a highly skilled Senior Quality Engineering Manager to lead our Quality Engineering team in the Advanced Drug Delivery segment at our Rockford, IL site.

Key Responsibilities
  • Provide leadership and direction to the Quality Engineering team to ensure the successful design transfer, risk management, and quality improvement projects.
  • Direct oversight of Quality Engineers responsible for the Advanced Drug Delivery business segment.
  • Lead the QE team to support New Product Introduction and tech transfer for product launches, as well as sustaining commercialized products.
  • Accountable for overall management, reviewing, planning, and administering of resource allocation and workload planning for the Quality Engineering staff.
  • Oversee and administer site risk management program aligned to ISO 14971.
  • Oversee and approve PCI investigations, including consumer complaints, trend investigations, calibration OOS, and laboratory or environmental monitoring product impact investigations.
  • Oversee and approve site supplier non-conformances and supplier-related quality metrics.
  • Oversee generation of documentation, such as Measurement System Analysis (MSA), Control Plans, Process Flow Maps, Inspection plans and techniques, GR&R, test requirements, and Test Method Transfer/Validation.
  • Technical evaluation of change controls, including risk assessment/implementation of risk mitigation strategies.
  • Apply scientific statistical analysis techniques to proactively identify trends, identify root causes, and implement actions to mitigate reoccurrence.
  • Statistical assessment of data to drive improvements.
  • Supports and maintains quality assurance programs and systems, policies, processes, procedures, and controls ensuring that performance and quality of products conform to established standards and agency requirements to ensure customer and regulatory satisfaction.
  • Participate as a member in various steering committees to guide and influence the company's focus on new products, new customers, and strategic initiatives.
  • Prepare reports to company management detailing the status of open projects that support the capacity, regulatory, and quality improvement requirements of the plant.
  • Presentation of quality standards, process flows, inspection plans, and/or issues both internally to stakeholders and externally to clients with confidence and accuracy.
  • Establishes and ensures the Quality Engineering team achieves the appropriate levels of compliance and develops actions to ensure ongoing performance is achieved and maintained through metrics and other forms of KPIs.
  • Support the recruitment, coaching, and development of quality engineers to achieve excellence and efficiency when programs are scaled.
  • Partner with internal teams (Business Unit, Quality, Operations, Engineering, Validation) to achieve company goals.
Requirements
  • College or Trade Degree required (engineering degree or related scientific degree).
  • Must have a minimum of 5+ 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 Qualifications
  • 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 is required.
  • Lean Six Sigma or other formal process improvement skillsets are highly desirable.
  • Technical knowledge and experience around Test Method validation, MSA, and Medical Devices processes are preferred.

  • Senior Quality Engineering Manager

    3 weeks ago

    Rockford, Illinois, United States PCI Pharma Services Full time

    Job Summary:The Senior Quality Engineering Manager will lead and direct the Quality Engineers for the Advanced Drug Delivery segment at the Rockford, IL site. This role is responsible for balancing client and product timeline commitments, ensuring the product is produced according to the established control plan, design and product specifications, and...

  • Senior Manager, Site Quality Management

    4 weeks ago

    Rockford, Illinois, United States Raytheon Technologies Full time

    Job Title: Senior Manager, Site Quality ManagementJob Summary:The Senior Manager, Site Quality Management, is responsible for leading a diverse team of quality professionals to ensure a healthy quality management system and robust product quality signature. This role oversees the Rockford Plant 1 facility, responsible for quality engineering, compliance,...

  • Quality Engineering Manager

    4 weeks ago

    Rockford, Illinois, United States PCI Pharma Services Full time

    Job SummaryWe are seeking a highly skilled Quality Engineering Manager to lead our Advanced Drug Delivery segment at our Rockford, IL site. As a key member of our team, you will be responsible for ensuring the quality and compliance of our products, while driving innovation and improvement in our manufacturing processes.Key ResponsibilitiesLead a team of...

  • Senior Manager of Engineering Operations

    3 weeks ago

    Rockford, Illinois, United States Volt Full time

    Job SummaryVolt is seeking a highly skilled Senior Manager of Engineering Operations to lead our engineering services team in Rockford, IL. This role provides leadership and direction in assessing, determining, and executing facility capital expenditures and maintenance enhancement needs with a focus on improving productivity and minimizing labor & overhead...

  • Quality Engineering Manager

    3 weeks ago

    Rockford, Illinois, United States RTX Full time

    Job Summary:RTX is seeking a Quality Engineering Manager to oversee the Quality Clinic and supervise the Quality Clinic Team at Plant 6. The ideal candidate will have a degree in Science, Technology, Engineering, or Mathematics (STEM) and a minimum of 8 years of relevant experience or an Advanced Degree in a related field and minimum 5 years of...

  • Quality Engineering Manager

    3 weeks ago

    Rockford, Illinois, United States RTX Full time

    About the Role:We are seeking a highly skilled Quality Engineering Manager to oversee the Quality Clinic and lead the Quality Clinic Team at Plant 6. As a key member of our team, you will be responsible for fostering a diverse culture of engaged and committed employees, supporting site Quality Management System in accordance with current quality standards,...

  • Senior Transportation Engineer

    4 weeks ago

    Rockford, Illinois, United States gpac Full time

    A leading engineering firm is seeking a highly skilled Senior Transportation Engineer to join their team. The ideal candidate will have a strong background in transportation design and project management, with a proven track record of delivering complex projects on time and within budget.The successful candidate will have a deep understanding of...

  • Senior Civil Engineer/Designer

    3 weeks ago

    Rockford, Illinois, United States IMEG Corp Full time

    Are you ready to take your career to the next level? At IMEG Corp., we're committed to providing exciting and rewarding career opportunities to our team members. We're passionate about what we do and strive to create a work environment that's both challenging and fun. As a company, we believe in investing in our team members and providing an environment for...

  • Senior Transportation Engineer

    4 weeks ago

    Rockford, Illinois, United States Harrison Consulting Solutions Full time

    Senior Transportation Engineer - Project LeadHarrison Consulting Solutions is seeking a highly skilled Senior Transportation Engineer to lead our project teams in the Rockford, Illinois office. As a key member of our team, you will be responsible for managing transportation projects from planning to completion, ensuring timely delivery and exceeding client...

  • Senior Structural Engineer

    3 weeks ago

    Rockford, Illinois, United States Elite Sourcing LLC Full time

    Job OverviewElite Sourcing LLC is a leading construction company seeking a highly skilled Senior Structural Engineer to lead our commercial projects. As a key member of our team, you will be responsible for designing and analyzing structural systems for various projects, ensuring the integrity and safety of buildings and infrastructure.Key...

  • Process and Quality Manager

    4 weeks ago

    Rockford, Illinois, United States Owens Corning Full time

    Process and Quality ManagerThe Process and Quality Manager provides technical leadership and hands-on guidance over the extrusion process and quality. Interfaces throughout all levels of the plant and the foam network to provide solutions and advancements to product manufacturing challenges. The Process and Quality Manager is the subject matter expert on the...

  • Clinical Quality Manager

    4 weeks ago

    Rockford, Illinois, United States PCI Pharma Services Full time

    Job Summary:PCI Pharma Services is seeking a highly skilled Clinical Quality Manager to join our team. As a Clinical Quality Manager, you will be responsible for planning, directing, and coordinating quality activities to ensure the goals and objectives of the team are accomplished within prescribed time frames and in budget.Key Responsibilities: Select,...

  • Senior Highway Engineer

    4 weeks ago

    Rockford, Illinois, United States Harrison Consulting Solutions Full time

    Job Title: Resident EngineerHarrison Consulting Solutions is seeking a highly skilled Resident Engineer to join their Rockford, Illinois area team.Job Summary:The Resident Engineer will be responsible for supervising construction on highway and/or roadway projects throughout areas of Illinois. This includes providing quality assurance to ensure projects...

  • Quality Assurance Manager

    4 weeks ago

    Rockford, Illinois, United States Waldo Electronics Full time

    Quality Manager Job DescriptionThe Quality Manager is a critical role at Waldom Electronics, responsible for overseeing and managing the quality assurance processes within our warehouses and offices. This position ensures that all activities comply with quality standards and regulations, maintains quality control procedures, and leads continuous improvement...

  • Clinical Quality Manager

    3 weeks ago

    Rockford, Illinois, United States PCI Pharma Services Full time

    Job Description:As a Clinical Quality Manager at PCI Pharma Services, you will play a vital role in ensuring the quality of our clinical services. Your primary responsibility will be to plan, direct, and coordinate quality activities for a designated clinical customer-focused team. This includes ensuring that team goals and objectives are accomplished within...

  • Process and Quality Manager

    4 weeks ago

    Rockford, Illinois, United States Owens Corning Full time

    Job SummaryWe are seeking a highly skilled Process and Quality Manager to lead our extrusion process and technical excellence. As a key member of our Plant Leadership Team, you will be responsible for driving excellent performance in our 24/7 extrusion process, delivering exceptional production performance, and constantly driving for improvement in product...

  • Senior Principal Engineer, Systems Engineering

    3 weeks ago

    Rockford, Illinois, United States Raytheon Technologies Full time

    Job SummaryAs a Senior Principal Engineer, Systems Engineering, you will be responsible for building domain knowledge in Systems Integration department in the field of electric and hybrid propulsion systems. You will work with System Integration Discipline Chiefs to adapt Chapter 24 domain knowledge of processes and aerospace engineering practices to system...

  • Quality Assurance Manager

    4 weeks ago

    Rockford, Illinois, United States LHH Recruitment Solutions Full time

    Job SummaryThe Quality Supervisor oversees the quality control and assurance of wastewater treatment processes, ensuring compliance with environmental regulations and industry standards. They manage a team of technicians, coordinate laboratory testing, and implement corrective actions to optimize treatment processes and improve overall efficiency.Key...

  • Fabrication Operations Manager

    4 weeks ago

    Rockford, Illinois, United States Sterling Engineering Inc. Full time

    Job Title: Fabrication LeadJob Overview:At Sterling Engineering Inc., we are seeking a skilled Fabrication Lead to oversee fabrication operations, ensuring efficient workflow and maintaining a safe work environment.This position reports to the Fabrication Foreman and is vital in meeting production schedules and quality standards.Key Responsibilities:Manage...

  • Senior Software Engineer

    1 week ago

    Rockford, Illinois, United States Modrow Insurance Agency Full time

    About the RoleAs a Senior Software Engineer, you will be responsible for designing, developing, and maintaining full-stack applications. You will work closely with our team to ensure that our software meets the highest standards of quality and functionality.Key Responsibilities* Design and develop full-stack applications using a variety of programming...