Quality Control Manager

Bio-Techne Wallingford , CT 06492

Posted 2 months ago

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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