Quality Control Manager

Bio-Techne Wallingford , CT 06492

Posted 2 months ago

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Job Details

Level: Management

Job Location: Wallingford - Wallingford, CT

Position Type: Full Time

Education Level: Bachelor's Degree

Salary Range: Undisclosed

Travel Percentage: Negligible

Job Shift: Day

Job Category: Operations

Description

By joining the Bio-Techne team you will have an impact on future cutting-edge research. Bio-Techne, and all of its brands, provides tools for researchers in Life Sciences and Clinical Diagnostics.

Position Summary:

Bio-Techne, is seeking a Quality Control Manager to oversee the day-to-day operations of the Quality Control department. Reporting to the Site Lead, this person will be a champion for Simple Plex consumables quality. Supports engineering, assay development and production teams during transfer from the validation phase onward. Supports applicable Quality Management System compliance activities. Responsible for day-to-day QC for the Simple Plex consumables production and provides on-going support to continuously improve the quality processes at this site.

Key Responsibilities:

Manage and lead the QC team including the Quality Supervisor, Quality Analysts and Quality Technicians including but not limited to; ensuring adequate staffing levels, recruitment, training, development, appraisal, and effective problem resolution that maximizes efficient productivity and delivers a high level of employee engagement.
Align with senior leadership initiatives and support corporate goals
Organize and schedule QC workflow to meet deadlines
Assess potential production risks and coordinate solutions with Operations team
Establish and monitor quality control systems including assessing risk within the quality program
Fosters and facilitates QA/QC Compliance with applicable standard
Development and ongoing maintenance of the quality department SOPs
Participate and support Material Review Board activities; Simple Plex Change Control board; Corrective Action teams, and provide Quality representation on special projects
Participate in supplier quality reviews
Monitor and report on customer quality metrics as input to management reviews
Perform Internal Audits as applicable
Support new product launch activities
Support validation activities related to design/process/equipment changes
Coordinate QC inventory maintenance activities with materials teams
Oversee incoming, in-process and final quality control testing as required
Oversee incoming inspection; process and qualify all inbound materials
Coordinate use of standard and improved quality tools among QC team
other duties as assigned

Qualifications

Education and Experience:

Bachelor's degree (minimum) in a scientific discipline, business, or engineering with 5+ years of related experience, preferably within the life science, biotech, or medical device industry.
Experience with operational process improvement initiatives
ISO 9001 experience required. ISO 13485 a plus. Strong understanding of quality system regulations and standards.
Experience with auditing Quality Management Systems
Experience developing, reviewing, deploying Standard Work (WI's, MI's, SOPs)
Strong leadership skills, with a proven ability to influence processes and outcomes in a highly cross-functional organization. Must be able to lead cross-functional teams to investigate complex issues and drive prioritized action(s) while employing risk-based, data driven thinking.
Strong presentation skills
Excellent computer skills and strong proficiency in MS Office
Experience with PLM applications preferred

Education and Experience:

Bachelor's degree (minimum) in a scientific discipline, business, or engineering with 5+ years of related experience, preferably within the life science, biotech, or medical device industry.
Experience with operational process improvement initiatives
ISO 9001 experience required. ISO 13485 a plus. Strong understanding of quality system regulations and standards.
Experience with auditing Quality Management Systems
Experience developing, reviewing, deploying Standard Work (WI's, MI's, SOPs)
Strong leadership skills, with a proven ability to influence processes and outcomes in a highly cross-functional organization. Must be able to lead cross-functional teams to investigate complex issues and drive prioritized action(s) while employing risk-based, data driven thinking.
Strong presentation skills
Excellent computer skills and strong proficiency in MS Office
Experience with PLM applications preferred

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