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Quality Manager

Date: Nov 27, 2018

LOCATION: Plymouth, MN, US

Company: Pelican Products, Inc.

We Build Careers As Strong As Our Products

 

Pelican BioThermal LLC is a global leader in the design and manufacture of single use and reusable temperature controlled packaging solutions for the highly regulated pharmaceutical, biotech, and clinical trials industries.  Pelican BioThermal is a great place to work and offers employees the opportunity to flourish and excel in a high-growth, fast-paced, creative, and exciting environment!  We currently have an opening for a Quality Manager based at our site in Plymouth, MN.

 

The Quality Manager is responsible for ensuring products, services, and quality system processes provided by Pelican BioThermal are of the highest quality, effectiveness, efficiency, and reliability.  This position ensures the effectiveness, efficiency, and continuous improvement of our quality system.

 

What You’ll Do:

  • Manages and provides leadership to Quality team including quality assurance, quality systems, and quality control.
  • Develops team members and manages their performance.
  • Ensures quality representation during design, process, and equipment reviews, verifications, and validations.
  • Provides oversight of product release, documents and records control, production and services quality, process deviation approval, change management, compliance, and nonconformance investigations.
  • Aligns site procedures and work instructions with the business unit quality management system Quality Manual, policies, and processes.
  • Oversees quality risk management activities, CAPA investigations, internal audits, complaint management, product returns, inspections, and training management.
  • Acts as the liaison to external bodies and agencies for the purpose of achieving and maintaining certifications and accreditations.
  • Coordinates management and reporting of site Key Performance Indicators (KPIs), including conducting periodic quality management reviews.
  • Supports in identifying, planning, and managing strategic quality initiatives at single or multiple sites.
  • Partners with Supply Chain Management to identify and qualify suppliers and monitor ongoing performance. Participates in or leads on-site audits of suppliers as needed.
  • Partners with Global Services to monitor ongoing quality performance of 3rd party Service Center and logistics partners.
  • Maintains and strengthens the site quality culture by ensuring all employees are aware of quality objectives, understand their impact on quality, and are trained on quality concepts and tools.
  • Performs other duties and work on special projects as required or assigned.

 

What You’ll Need:

  • Education:  Bachelors Degree or equivalent in Quality Assurance, manufacturing, engineering, or another related field.
  • Minimum of 5 years of experience in quality systems management, preferably in an ISO 9001 certified and/or life-science regulated environment (pharmaceutical, biologics, or medical device).
  • Experience in a manufacturing or packaging operation, familiar with engineering and manufacturing documentation.  
  • Must have excellent analytical and organizational skills, be detail-oriented and able to work under minimum supervision.
  • Must have excellent written, negotiation, presentation and verbal communication skills.
  • Proficient in Microsoft Word, Excel, PowerPoint, Outlook, Project and/or other appropriate software tools.
  • Must be a self-motivated, proactive, focused high-achiever who consistently delivers results and has the ability to make rapid adjustments in response to changing priorities.
  • Actively supports and complies with Pelican BioThermal’s objectives, guidelines and commitment to Quality and Safety, with an emphasis on continual improvement.
  • Must be able to operate in a fast-paced environment and handle multiple projects simultaneously.
  • Ensures that staff is contributing at maximum potential through rigorous hiring practices and an emphasis on training and development initiatives, including coaching and counseling direct reports in their performance and professional development, with final authority for approving pay increases, hiring decisions and disciplinary actions.
  • Emphasizes ethical leadership and decision-making to protect Pelican BioThermal’s brand and reputation.
  • Must be able to travel locally and internationally to visit customers, suppliers, subcontractors or other Peli/Pelican sites when necessary up to 25%.

 

Bonus Points For:

  • Certification in quality, configuration management, records management, or related areas.
  • Certified Lead/Internal Auditor.
  • Knowledge of the cold chain industry and technologies.
  • Working knowledge of SAP or a similar ERP system

 

Why Join Pelican BioThermal? Here’s a glimpse of Pelican Perks…

  • Generous paid time off plans.
  • 401k plan – with a competitive match.
  • Tuition Assistance Program.
  • Established reputable brand offering premium products – you’ll be proud to represent Pelican!
  • Employee discount program on Pelican Products.
  • Great Benefits – several options including Pet insurance for our animal lovers.
  • Wellness Discount Program.
  • Lucrative employee referral program – get paid to work with your trusted network.
  • And more…

 

Pelican BioThermal is an Equal Opportunity/Affirmative Action employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

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