Senior Quality Engineer

Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.

Quality Assurance develops and implements a compliant and cost-effective quality system that assures products and services are reliable, safe and effective.

This job family provides oversight of production / manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures and ensures that all products and services are properly reviewed for quality and documented.

Responsibilities :

Responsible for seeing that all tasks are performed in a manner that complies with site and corporate QMS.

Support Quality Assurance System

Manage / support internal audit program including conducting quality audits. Develop subsequent corrective / preventive actions for internal audits.

Conduct QA system training.

Conduct month end trend and report metrics, weekly, quarterly in Management Review.

Manage databases for compiling and reporting metrics

Create and present Quality Alerts for manufacturing awareness, reinforcement of Quality requirements.

Manage / Support CAPA program, determine root cause and / or preventative actions, and follow up on CAPA actions and due dates.

Mentor CAPA champion and team members.

Monitor / support supplier performance.

Manage / support SCAR program, initiate SCARs, and track SCAR corrective actions and due dates. Perform supplier audits and initiate / monitor follow up actions as required.

Perform / support customer complaint investigations for area of responsibility. Determine root cause / corrective and / or preventive action for customer complaints and externally generated customer SCARs.

Manage / support nonconformance program for area of responsibility. Facilitate and approve root cause / corrective and / or preventive actions for nonconforming material and / or material on hold.

Facilitate MRB and recommend disposition of nonconforming product.

Manage and / or participate on quality improvement projects including collaboration with R&D, Marketing, Regulatory, Stability Services, and Clinical Affairs.

Support cost savings projects.

Use of statistical tools to perform analysis and data trending.

Perform process risk assessment and failure mode effects analysis (PFMEA).

Develop specifications and test methods to meet customer, product and internal quality requirements. This may include writing procedures to carry out requirements.

Review new and modified product designs and processes for quality compliance.

Participate in applicable Quality System Standards and Regulations, FDA, supplier, customer, and internal audits as required.

Represent the Quality function on new product development / process transfer projects. Provide quality engineering support for new product development.

Lead and participate in production floor support / continuous improvement initiatives.

QA Improvement Training (SPC, Five-Why, FDA etc.).

Maintain and evaluate sampling plans. Update / revise product control plans, inspection and test standards, and other site documentation where necessary.

Document Change Request (DCR) reviews and approvals.

Monitor and maintain facility Sterilization (pre and post- sterilization procedures) / Environmental Monitoring if applicable.

Monitor bioburden and dose audits for sterile product.

Receive general guidance and may receive more detailed instruction on new projects.

Performs other job duties as assigned.

Qualifications :

Bachelor’s degree in related field, or equivalent work experience, preferred

2+ years’ experience in related field preferred

Understanding of FDA regulations surrounding the manufacturing of medical devices, GMPs and process validations would be an asset

Able to apply working knowledge in the application of concepts, principles, and technical capabilities to perform varied tasks

Experience working on projects of moderate scope and complexity

Ability to identify possible solutions to a variety of technical problems and take actions to resolve

Able to exercise sound judgment within defined parameters

Strong PC skills and knowledge of MS Office preferred

What is expected of you and others at this level :

Applies working knowledge in the application of concepts, principles and technical capabilities to perform varied tasks

Works on projects of moderate scope and complexity

Identifies possible solutions to a variety of technical problems and takes action to resolve

Applies judgment within defined parameters

Receives general guidance and may receive more detailed instruction on new projects

Work reviewed for sound reasoning and accuracy

Anticipated salary range : $66,500 - $95,000 / year

Bonus eligible : No

Benefits : Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

Medical, dental and vision coverage

Paid time off plan

Health savings account (HSA)

401k savings plan

Access to wages before pay day with myFlexPay

Flexible spending accounts (FSAs)

Short- and long-term disability coverage

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Application window anticipated to close : 09 / 08 / 24 *if interested in opportunity, please submit application as soon as possible.

The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate’s geographical location, relevant education, experience and skills and an evaluation of internal pay equity.

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day.

Cardinal Health is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity / expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.