Title:  Quality Auditor Supervisor

Job Summary

In this role, the QC supervisor will be to ensure safe, compliant, and efficient operations in the Quality Control department. He/she will manage directly and closely support the quality inspectors in all areas. He/she will assist QC Manager to build-up a team of competent QC inspector to achieve consistent compliance and timely execution of tasks. Responsible for Safety, accountable for adherence to procedures, quality and schedules on assigned shifts; promote effective team member/Company relations to help improve team engagement, customer service and Company profits. #LI-AP1 #LI-ONSITE

Essential Duties and Responsibilities

• Supervise shift personnel in the quality control department consistent with high safety and quality standards.
• Troubleshoot problems arising on the shop floor in conjunction with quality standards with the appropriate engineering support from Quality Engineering functions.
• Maintain close observation of quality requirements to keep quality management informed of status and, when needed, initiate the necessary steps to conform to schedule / staffing requirements.
• Promote and support site initiatives including quality safety programs, lean initiatives, training programs, and consistently interpret and apply all policies, practices and procedures among plant team members.
• Recommend and implement measures to motivate team members and to encourage employees to recommend ways to improve process, quality, safety and efficiency.
• Routinely evaluate team member performance and identify training needs. Coach and counsel team members for performance, attendance and behavior. Participate in the resolution of team members relations issues.
• Review and approve work time in the appropriate timekeeping system. Maintain and verify accuracy of the hours each team member has worked.
• Works independently to identify Quality issues, initiate nonconformance reports, and recommend corrective actions.
• Determine product acceptability by performing various types of inspections and measurements utilizing varying laboratory equipment and taking care of valid calibration (internal and external).
• Create, utilize, and maintain testing result forms.
• Develop sampling plans and activities, as required.
• Authoring of quality notifications such as deviations and OOS (visual and dimensional).
• Support review of batch production records and perform review, approval, and release of product and materials within the inventory management/ERP system.
• Ensures compliance with quality system documents, cGMPs, ISO standards and FDA regulations.
• Work with technical staff in performing root cause failure analysis and implementing corrective and preventive actions to eliminate recurrence.
• Manage the team’s performance, conduct performance 1 to 1’s, support recruitment, training and development plans while addressing any issues that arise in a timely manner.
• Liaise with internal and external customers and other departments as appropriate.
• Ensure that the QC inspection conducted are performed according to relevant procedures and data reported in compliance with data integrity principles.
• Act as a central point of communication for all departments in respect to product quality issues on the shop floor and ensure that these are escalated appropriately.
• Other duties as assigned.

Additional Responsibilities

• Participate in special project teams as assigned.
• Performs other duties as assigned based on business needs.
• Conforms with and abides by all laws, regulations, safety rules, policies, and work procedures, and all instructions.
• Exhibits regular, reliable, punctual and predictable attendance.

Education

• Associate's Degree in Technical or Engineering required
• Bachelor's Degree in Technical or Engineering preferred

Work Experience

• 5+ years experience in regulated Quality Assurance and or metrology and Document/Configuration Control (or a formal education equivalent) required.
• Experience with Medical Device Product Development Life Cycle Activities, Verification / Validation Activities, Metrology/Manufacturing background and Risk Management preferred.
• Experience with quality systems such as ISO 13485 and 21 CFR 820 preferred.
• Experience with MasterControl, SAP, and SharePoint preferred.
• Experience with customer interface and meeting customer expectations preferred.
• 3+ years of supervisor experience preferred.

Preferred Knowledge, Skills and Abilities

• Ability to work independently, multi-task and thrive in fast-paced environment.
• Excellent written and verbal communication skills.
• Proficient in statistical software, Windows OS, Microsoft Office Suite including Word, Excel, and PowerPoint.
• Proven knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO) ISO 13485.
• Familiarity with root cause analysis tools.
• Working knowledge of MasterControl and SAP.
• Support and contribute in Lean Sigma programs and activities towards delivery of the set target.
• Ability to make and implement decisions based on experience and facts as well as provide direction to peers or less experienced team members.
• Able to be aware of all relevant SOPs as per Company policy and Quality Manual.
• Able to comply with the company’s safety policy at all times.

Travel Requirements

Physical Requirements

Additional Requirements

• Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events.
• Must maintain the ability to work well with others in a variety of situations.
• Must be able to multi-task, work under time constraints, problem solve, and prioritize.
• Ability to make independent and sound judgments.
• Observe and interpret situations, analyze and solve problems.
• Maintain high attention to detail, accuracy, and overall quality of work.
• Effectively communicate and interface with various levels internally and with customers.

What We Offer

Shift

Monday through Friday.