Supervisor - IQA (Incoming Quality Assurance), 1st Shift

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

This role provides a unique opportunity to make a large impact within a fast paced and growing medical device manufacturing organization. As the Quality Control Supervisor, you are responsible for ensuring company products are in compliance with internal and external specifications by managing and supervising a team of technicians who performs a variety of routine and non-routine inspections and evaluations generally of finished goods, components, and incoming materials through manual (visual, calipers, height gages, etc.) and automated testing (CMM, O-Inspect, Keyence).

You will also spend time working to grow and develop talent, complete projects with cross functional teams and drive continuous improvement initiatives.

Key Responsibilities

• Responsible for managing and supervising the Incoming Quality Assurance department and its technicians/inspectors in the day-to-day execution of customer/departments requests for incoming inspection.
• Responsible for mentoring, conduct performance reviews, creating training plans and delivering training to technicians/inspectors, in addition to identifying staff development needs in areas such as GMP training, technical skills, safety, performance management and best practices. 
• Communicates department objectives and metrics. Implements changes in production methods, tooling and equipment, space allocations, workforce utilization, production schedules, lines and other factors required to maintain or improve compliance with quality standards of existing products and to establish initial and continuing compliance with quality standards for new and/or redesigned products.
• Be the main point of contact to Senior Staff, Operations, Quality, Planning, Engineering, Materials and other departments for incoming inspection to ensure timely execution of needed activities for inspection planning, inspection results and back order demands as required.
• Provides input to Incoming Inspection reports, requirements and other information in response to requests for proposals, quotes and other business opportunities. Provides input to budget planning process. Utilizes cost control initiatives to reduce expenses. Makes recommendations to management regarding ways to improve manufacturing processes and increase product quality and delivery while reducing production costs.
• Responsible for good housekeeping and safety procedures in the inspection areas.
• Alerts the organization to issues in time to resolve potential adverse effects on the customer, company image, or reputation of the business. Provides complex product team support for quality system design and audit, compliance assessment, and for support of steady state distribution processes.
• Reports on management reviews. Review/analyze whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc.
• Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.
• Conduct periodic line audits to assess for production controls such as lot segregation. Conducts investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
• Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in the distribution site.
• Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality
• Document, justify, review or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard such as the QSRs
• Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Determine effectiveness of these techniques on previously implemented improvements
• Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support. Develop, interpret and/or implement standard and non-standard sampling plans; and supports LEAN, JJOS and Six Sigma Initiatives.

Minimum Qualifications:

• BS in any engineering discipline or related technical field preferred. Associate degree acceptable with appropriate experience.

Preferred Qualifications

• 2+ years of first line supervisory experience with direct people management and/or project management experience is preferred.
• A minimum of 5 years’ of IQA professional experience, which includes experience in a GMP, FDA and/or ISO regulated industry recommended.
• Experience working in manufacturing/operations is preferred.
• Experience in a highly regulated industry – medical device/aerospace/automotive preferred.
• Ability to motivate and influence a team
• Knowledge of product/process Risk Management (FDA and ISO standards) is required.
• Ability to perform "hands on" troubleshooting and problem solving is required.
• Advanced Technical Training and experience using Statistics, Lean and Six Sigma Methodologies is preferred, including Measurement System Analysis, SPC, DOEs, Reliability, etc.
• Technical understanding of manufacturing equipment and distribution processes is preferred.
• Experience with MRP / ERP systems, preferred.

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