Quality Control Supervisor - Healthcare Components Group

Job Summary:

Responsible for leading the Quality Control department to ensure compliance with corporate policies, procedures and regulations. Oversee and perform daily responsibilities related to supervision of quality control for all materials, supplies, parts and finished products.

Duties and Responsibilities:

1. General responsibilities include supervision and hands-on performance of the following:

• Coordinate with other departments to maintain physical inventories necessary for order fulfillment and support production activities.
• Communicate with other departments regarding Receiving and Quality Control requirements.
• Participate in production planning meetings.
• Record, Disposition and Investigate non-conformance reports (NCRs), CAPAs, and return material authorization (RMAs) in a timely manner.
• Maintain a clean and orderly work environment.
• Performing other tasks as deemed necessary by the Director of Quality.

Technical supervision duties include development and implementation of: QC Inspection Plans, Statistical Sampling Requirements, Supplier/Item Performance Metrics, Inspection Procedures and Forms Supervisor Responsibilities

• Schedule personnel and assignment of work tasks to ensure appropriate coverage to support operations and business needs.
• Measure team progress against team and site goals and KPIs.
• Provide goals and mentoring/coaching for personnel.
• Provide primary input for personnel reviews and provide immediate feedback to personnel on performance.
• Develop and provide training to personnel.
• Ensure department operates within budget.

Qualifications

• Bachelor's degree in Life Sciences or engineering related field or other closely related discipline.
• Minimum of 5 - 7 years of relevant work experience. cGMP regulated environment preferred.
• Previous leadership / supervisory / management experience required.
• Working knowledge of ISO 9001, ISO 13485 or similar Quality Management System requirements
• Ability to read, analyze and interpret technical procedures and governing policies.
• Strong interpersonal and influential skills
• Excellent in communication and project management
• Decision-making based on a science-based risk approach.
• Ability to work (and lead team efforts) on multiple priorities simultaneously.
• Detailed Oriented with ability to work under tight deadlines handling multiple priorities.
• Experience with word-processing, spreadsheet, and presentation software (e.g., Adobe Acrobat, MS Word, Excel) a must
• Knowledge of typical QC measurement tools (i.e., Calipers, Micrometer, Steel Rules, Pin Gages, Optical Comparator, etc.)

Must have demonstrated ability to perform the following:

• Effectively execute the above listed duties and responsibilities.
• Follow written and verbal directions with limited oversight.
• Effectively communicate, read and write in English language.
• Perform and instruct others in detail-oriented receiving and quality control inspection techniques.
• Multi-task with frequent interruptions in a fast-paced environment.
• Effectively manage multiple personnel to prioritize and accomplish multiple tasks.
• Interpret technical drawings and diagrams.

Working Conditions:

• The job is performed at our facilities in a climate controlled non-smoking environment. It requires a person to workday shift and overtime as peak workload may require.

Physical/Mental requirements

• The job requires standing and sitting for extended lengths of time and the ability to lift and manage packages and products weighing up to 30 lbs.
• Ability to perform complex data analysis.

Other Requirements:

• Position requires regular onsite attendance. Travel between locations required.
• Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications, and attending multiple meetings and conference calls. Note that these activities may not be time bound to core hours or presence at the site.
• Must have the ability to work effectively under and manage to strict production, time and performance deadlines.
• Must be willing and able to work beyond the hours typically defined as a "regular" workday, which may or may not include weekends and holidays.

Reports to:

Directory of Quality

Direct Reports:

Quality Control Specialists

Quality Control Inspectors