Quality Manager, Medical Device Manufacturing

What Quality Management contributes to Cardinal Health
Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.

Quality Management provides strategic oversight, leadership and direction within the Quality function.

What is expected of you and others at this level

• Manages department operations and supervises professional employees, front line 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, peers, customers, and suppliers at various management levels; may interact with senior management
• Interactions normally involve resolution of issues related to operations and/or projects
• Gains consensus from various parties involved

Responsibilities

• Knowledge of standards that the facility is certified to and that the Quality Management System is modelled after. Maintain certificate requirements and updates.
• Manage Quality budget. Allocate resources, tools and equipment as required for the department.
• Manage Change Control for site; Support Cost savings and continuous improvement initiatives throughout the facility. Provide training and guidance on approach to changes.
• Holding Management Review meetings as scheduled and following up on improvement actions.
• Manage the facility Internal and Supplier Audit program and participate in ISO, FDA, corporate and customer audits as required.
• Presentation Skills: Be able to train and or present quality information to facility, outside contacts.
• Support process validation and calibration programs and activities for the facility.
• Manage the non-conformance program for the facility. Support non-conformance closure for product and material on hold, facilitating Material Review Boards to determine disposition of nonconforming products.
• Manage Customer Complaints program. Investigate and respond to customer complaints, including facilitating Material Review Boards to determine disposition of nonconforming product.
• Manage and maintain facility CAPA program and support continuous improvement initiatives.
• In conjunction with R&D, Operations and Sales and Marketing, develop specifications and test methods to meet customer, product and internal quality requirements. This may include writing procedures to carry out requirements.
• Implement and maintain sterilization programs for products, including pre-sterilization and post-sterilization procedures, documentation, review of results and release to inventory.
• Implement and maintain Supplier Performance as it relates to product quality, Supplier Corrective Action and Calibration systems. Conduct Supplier Audits. Coach and train new auditors.
• Manage and maintain the Quality Document Control System for the facility. Manage Artwork files for facility, manage labelling database for all products, including creation in label software and GTINs for all finished goods.
• Conduct communication of quality internally and externally on a daily, weekly, monthly, and quarterly basis. Provide Quality Metric data, reports as assigned.
• Support Training requirements for facility, conduct Quality orientation, defect training and product awareness. Support training software that houses all electronic training and maintain skills matrices for facility.
• Managing and overseeing all incoming raw material receiving and inspection activities as well as finished product release requirements.
• Ensure Quality record retention requirements are maintained and controlled as outlined in quality procedures.

Direct Reports: Senior Quality Engineer, Quality Engineers, Document Supervisor.

The Quality Manager is the Management Rep for the facility. The Management Representative is responsible for:

• Leading in the development, implementation and maintenance of processes needed for a quality management system that meets all applicable quality system standards and regulatory requirements relevant to the current business.
• Ensuring that the quality management systems requirements are effectively established and maintained.
• Reporting to top management on the performance of the quality management system.
• Ensuring the promotion and awareness of the regulatory requirements throughout the organization.
• Initiating, recommending or providing solutions for product and quality management system related problems and/or improvements.
• Driving key initiatives and embedding the quality culture.
• Maintaining connections within the organization to identify opportunities for harmonization, alignment and continuous improvement of practices associated to quality management system processes.

Qualification:

• Bachelors degree preferred and/or equivalent experience
• 8 12 years in engineering or QA preferred. MDR and CMDR experience preferred

• FDA Regulated Industry experience as well as applicable Quality System Standards and Regulations experience

• Project Management, SPC, DOE, FMEA, sampling plans, statistical knowledge, technical writing skills
• Superior leadership, facilitation, and communication skills
• Six Sigma Training/Lean Manufacturing Training is an asset
• Good working knowledge of mechanical inspection techniques and equipment
• Basic SPC skills and statistical sampling methods
• Strong computer Skills; email, word, excel, power-point, Minitab
• Good working knowledge of all products manufactured including product development, complaint processing, raw materials verifications, sterile products procedures
• Certified Internal Auditor
• Strong communication skills
• Experience in training, Train the trainer certification

Anticipated salary range:$88,800 - $126,800

Bonus eligible:Yes

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:04/12/2024 *if interested in opportunity, please submit application as soon as possible.

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.