Cardinal Health Principle Engineer, Quality Program Manager in Waukegan, Illinois

The position will manage quality projects and programs at the corporate and business unit level.

What Quality Engineering contributes to Cardinal Health

Quality Engineering is responsible for product and service quality planning, evaluation and control. Works cross-functionally in the development and implementation of prevention based methodologies used in design, manufacturer, test, sustainability and correction of products and services.

  • Demonstrates understanding of quality philosophies, principles, systems, methods, tools, and standards.
  • Demonstrates understanding of the audit process including types of audits, planning, preparation, execution, reporting results and follow-up.
  • Develops and implements quality programs, including tracking, analyzing, reporting and problem solving.
  • Plans, controls, and assures product and process quality in accordance with quality principles, which include planning processes, design control, material control, acceptance sampling and measurement systems.
  • Demonstrates knowledge of reliability, maintainability, and risk management, including key terms and definitions, modeling, systems design, assessment tools and reporting.
  • Applies problem solving and quality improvement tools and techniques, including, preventative and corrective actions and how to overcome barriers to quality improvements.
  • Acquires and analyzes data using appropriate standard quantitative methods to facilitate process analysis and improvements.

Principle Quality Engineer/Quality Program Manager

• Manage projects and activities for the corporate quality group and key quality system programs such as:

o Non-conformance Management

• Lead, cross functional teams and execute validation activities for:

• Design Verification and Design Validation

• Process Validation

• Provide guidance for risk management activities, including recommendation and execution of

• risk assessments (FMEAs, complaints, NCMR’s)

• field impact assessments (stand alone, CAPA’s, complaints)

• Support key quality system programs such as internal audits, CAPA, and shelf life establishment

• Report on quality systems in quarterly Management Review meetings, as applicable

• Provide continued quality system support by improving processes and systems and by updating and creating SOP’s to ensure conformance to national and international regulations

• Participate in third party (Notified Body, FDA) audits as a subject matter expert for quality system compliance

• Interface with internal constituents and external regulatory bodies regarding compliance needs for areas managed

• Provide root cause analysis and statistical support to resolve production issues

• Partner with Operations to provide validation and verification plans for design and process changes

• Review and/or approve complaint investigations, MDRs, marketing promotional literature, marketing post market surveillance materials and engineering notifications

• May support product development and manufacturing improvement projects, including:

• Coordinate risk management activities (FMEA, Hazard Analysis, Risk Management Plan and report, etc)

• Identify testing and analysis required for the finished device to ensure device conformance to product specifications;

• Provide support for process validation and design transfer activities.

• Work closely with the product development group to ensure marketing/product specifications are aligned and integrated into the Design Control Process from Design Input creation through product release

Qualifications:

• Demonstrates extensive hands-on experience in FMEA, Hazard Analysis, DOE, gauge R&R, SPC, GMP, MDD 93/42/EEC, ISO13485, 21 CFR Part 820, ISO 13485:2016, design controls, process validation, design validation, complaint handling and investigations, internal auditing, and hosting FDA and other regulatory inspections.

• Experience and involvement in MDRs, and 510k submissions.

• Possesses excellent communication skills with all levels of management and technical organization

• Competence in evaluating new test methods, processes and materials to determine effect on project deliverables

• Ability and experience to work cross functionally as a leader and SME in Quality Compliance with Engineering, Manufacturing, Operations, Regulatory Affairs, and Field Reps.

• Strong working knowledge of Design control in a FDA regulated industry

• Require GMP (21CFR820) and ISO 13485 knowledge and experience

• Statistical knowledge including sampling plans, control charts, DOE, ANOVA etc.

• Excellent interpersonal skills, self-starter and self-motivated

• Excellent technical writing skills with CE marking knowledge preferred.

Education and/or Experience:

• Bachelor’s degree required, in Engineering preferred.

• Certifications preferred, such as CQE, CMQ/OE, CQA/CBA, Lead Auditor.

• Minimum 5 years of experience in medical device industry.

• Ability to perform internal and external quality audits required.

• Prior experience in supplier management – Contract manufacturers preferred.

• Experience in data mining, trend analysis and presentation preferred

What Quality Assurance contributes to Cardinal Health

Quality Assurance is responsible for developing and implementing a compliant and cost effective quality system that assures products and services are reliable, safe and effective.

• Demonstrates knowledge of quality systems and approaches.

• Demonstrates an understanding of the relevant regulations, standards and operating procedures.

• Demonstrates ability to perform investigations / root cause analysis and develop corrective actions.

• Demonstrates an understanding of the requirements and has the ability to perform gap assessments to those requirements.

• Demonstrates an understanding of quality concepts such as: cost of quality, analytical metrics and / or statistics, trending, quality planning, validation, CAPA and problem solving.

• Works cross-functionally and has the ability to interpret the requirements as well as educate and influence others on those requirements.

Qualifications

• Bachelors in related field, or equivalent work experience, preferred

• 8+ years experience in related field, preferred

What is expected of you and others at this level

• Manages department operations and supervises professional employees, frontline supervisors and/or business support staff

• Participates in the development of policies and procedures to achieve specific goals

• Ensures employees operate within guidelines

• Decisions have a short term impact on work processes, outcomes, and customers

• Interacts with subordinates, peer customers and suppliers at various management levels may interact with senior management

• Interactions normally involves resolution of issues related to operations and/or projects

• Gains consensus from various parties involved