Experienced Quality Manager with a Food/Medical Device Background Needed!

Description:

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

Provides direct supervision, resolves personnel issues, conducts performance evaluations, and performs managerial discipline, as necessary.

• Direct reports include quality control supervisors

• Leads and directs the Incoming Inspection, In-Process Inspection, and Batch Release 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 opportunities 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 cause failure analysis and implementing corrective and preventive actions to eliminate 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 KPIs metrics.

• Determines/sets Goals & Objectives for the Quality control organization and training programs for team's development purposes.

• Supports investigations related to Non conformances, Audit observations, CAPAs, or Issue Reviews as needed.

• Ensures equipment is up to date on Preventive maintenance and calibration activities.

• Maintains the lab/area well organized with a 5S mindset.

Skills:

quality control, iso standards, inspection, kpi, metrology, sop's, lean six sigma

Additional Skills & Qualifications:

+ KSAs Metrology Equipment experience

+ Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description

+ 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

Experience Level:

Intermediate Level

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

+ Hiring diverse talent

+ Maintaining an inclusive environment through persistent self-reflection

+ Building a culture of care, engagement, and recognition with clear outcomes

+ Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] (%[email protected]) for other accommodation options.