Quality Systems and Compliance Manager

Job Summary

In this role, you will monitor and control the daily activities of quality inspections of incoming, in-process, final, and batch record review and release. In this position, you will manage the Quality Control team to ensure the inspection process is executed in a proper and timely manner by ensuring procedures are followed and imporved as part of a continuous improvement mindset.

Essential Duties and Responsibilities

• Provides direct supervision, resolves personnel issues, conducts performance evaluations, and performs managerial discipline, as necessary.
• Direct reports include quality compliance supervisors.
• Leads and directs the Quality Engineers, Audits and Compliance Teams with a positive and patient attitude.
• Maintains and instills in others a "quality at the source" mentality as it pertains to all aspects of manufacturing, including documentation, training, and other functions related to production.
• Maintains and instills in others an "immediate audit readiness" mentality so that records and actions are executed in a way that ensures their accuracy, legibility, and immediate retrievability.
• Ensures compliance with quality system documents, cGMPs, ISO standards and FDA regulations.
• Schedule and prioritize quality inspection, testing, and batch record review and release to support Operations and release of product.
• Identifies and develops opportunitites to improve existing processes and procedures
• Support quality assurance improvement activities by evaluating products, processes or materials in order to develop control or improvement strategies intended to improve the customer's experience.
• Work with technical staff in performing root caue failure analysis and implementing corrective and preventative actions to elimiate recurrence.
• Manage the verbal communications and visual checks of work activity to ensure quality requirements are met.
• Ensure proper corrective actions, discrepancy reports, and follow up activities are accomplished.
• Reviews documentation and records for accuracy. Determines if product is impacted, can be released, or if Non-Conformance Report is required.
• Manages the development of documentation and procedures during the qualification of new equipment/inspection methods.
• Exhibits regular, reliable, punctual and predictable attendance.
• Creates, prepares, implements and improves Quality Control KPI metrics.
• Determines/sets goals and objectives for the Quality Control organization and training programs for team's development purposes.
• Supports investigations related to Non conformances, audit observations, CAPA's, or issue reviews as needed.
• Ensure equipment is up to date on preventative maintenance and calibration activities.
• Maintains the lab/area well organized with a 5S mindset.
• Other duties as assigned.

Education

• Bachelor's Degree in Technical or Engineering or equivalent field required

Work Experience

• Minimum 8 years in quality control required
• 3+ years of supervisory experience required

Preferred Knowledge, Skills and Abilities

• Metrology Equipment experience
• Support and contribute in Lean Sigma programs and activities towards delivery of the set target
• Able to comply with the company’s safety and quality policies at all times

License and Certifications

• Certified Manager of Quality/Operational Excellence preferred

Travel Requirements

Physical Requirements

Additional Requirements

• Must be able to work assigned shift(s) with overtime as required to complete assignments if necessary. Sitting and/or standing for extended periods may occur as well as getting to and from offices and building sites. If necessitated by customer requirements, must be able to see with or without corrective lenses and distinguish color differences for product and safety issues. Hearing ability should be sufficient to hear and react to audible alarms from distances up to 150 feet. The ability to be able to lift and carry various items up to 50 pounds for manufacturing positions or 30 pounds for administrative positions is required.
• This job requires decision making based on data analysis.
• Must be able to generate, express, and exchange new ideas.
• Must be able to understand direction and adhere to established procedures.
• Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read and write, speak in front of groups, express and exchange ideas, understand direction and adhere to procedures
• Organizational skills will enable planning, prioritization and achievement of goals especially of importance for the successful execution of related activities
• Read and interpret data, information and documents.
• 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.

What We Offer