QC Supervisor

POSITION SUMMARY:

This position will assure that all Omron Healthcare products are of high quality by developing, maintaining and managing the Quality System for compliance with FDA, ISO, Canadian Medical Device and other International Ministry of Health requirements applied to currently approved products and products under development.

RESPONSIBILITIES:

• Manage exempt and nonexempt employees at the Inspection Center. Responsible for the overall direction, coordination, and evaluation of the QC department. Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training QC employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
• Conduct internal and supplier audits. Assist with 3rd party regulatory audits.
• Conduct Product Evaluation reviews (PEFs)
• Manage testing procedures based on new and revised product service manuals and updates from OHQ.
• Manage and maintain testing and software equipment including validation, calibration, procurement and installation.
• Manage inspection center costs including shipping and other charges (FedEx, Uline, etc.)
• Managing the IC task schedule, formulating and monitoring quality measurements and objectives, and conducting skill competency assessments.
• Direct Inspection Center personnel engaged in inspection and testing activities to ensure continuous control over materials, facilities, and product.
• Creation, distribution, management and follow up on all Supplier Corrective Action Requests (SCAR)
• Move all product from QC to stock in JDE.
• Creation, distribution, management and follow up of damage product.
• Manage post market quality processes including complaint investigation requests initiation, reporting & follow ups (CIRs)
• Create, distribute and lead Quality System Complaint Review meetings.
• Communicate and work effectively with offshore manufacturing and with marketing for new product launches.
• Demonstrate capability to communicate and work effectively with offshore manufacturing and with marketing for new product launches.
• Identify and execute solutions to existing processes, and develop new quality system processes to ensure compliance with applicable guidelines for medical devices.
• Provide coaching and advice to managers and employees on practical application of Quality System requirements.
• Lead and participate in continuous improvement initiatives for development and execution. Identify the improvement, develop the solution, lead the execution, and engage other functional areas as needed. Report progress to executive management team.
• Maintain high visibility and interaction with team members to foster collaboration and teamwork. Interact with other departments, manufacturers, and suppliers.

EDUCATION, EXPERIENCE AND CERTIFICATIONS:

• Education: Sciences degree or equivalent experience.
• Experience: Minimum 5 year’s experience in a health sciences, regulatory, clinical, QA, QC, or other related technical field in an FDA regulated industry. Experience with medical devices, electronics, and/or consumer electronics is strongly preferred. Experience in interactions with FDA, regulatory authorities, and/or ISO/CMDCAS notified bodies required.

KNOWLEDGE, SKILLS AND ABILITIES - The responsibilities listed below are representative, but not all inclusive of the knowledge, skill, and/or ability necessary to satisfactorily and successfully perform the essential duties of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

• Technical Abilities: Well-developed small electronics and/or computer maintenance, PC skills and knowledge of Microsoft applications (Office, Excel, etc.) or equivalent required.
• Behavioral Profile:
• Strong planning, organizational and time management skills.
• Able to handle multiple projects simultaneously.
• Attention to detail, and good problem solving skills.
• Self-motivated and able to work independently.
• Excellent listening and communication skills with strong ability to create and build relationships.
• Basic understanding of business terms and processes.
• Ability to multi-task, work cross-functionally and independently with strong organizational skills. Excellent people skills.
• Ability to analyze processes and information, identify problems and trends, and develop effective solutions and strategies

QUALIFICATION REQUIREMENTS - The requirements listed below are representative of the physical and environmental factors the jobholder will encounter. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

• Physical Requirements: While performing the responsibilities of the job, the employee is often required to talk, hear at normal speaking levels, sit and use their hands and fingers to type, handle or feel, including repetitive motions with the wrists, hands and fingers. The employee is occasionally required to stand, walk, and reach with arms and hands, this is a sedentary position involving sitting most of the time. Vision abilities required by this job include close vision for extensive computer use, reading and visual inspections.
• Environmental Factors: While performing the duties of this job, the employee is primarily in a general office environment and occasionally in other. The noise level in the work environment is usually quiet to moderate. The position is not substantially exposed to adverse environmental conditions.
• Travel Requirements: Must be able to travel to the warehouse located in Joliet, IL 30%

CONCLUSION: This job description is intended to convey information essential to understanding the scope of the job and the general nature and level of work performed by jobholders within this position. However, this job description is not intended to be an exhaustive list of qualifications, skills, efforts, duties, responsibilities or working conditions associated with the position.

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