Quality Coordinator

Posting Date: 05/09/2019
Closing Date: 07/09/2019
Posting Level: Mid-Level

Wilson Wolf Manufacturing Corporation is a privately held, fast-growing Class 1 medical device company in New Brighton, MN with a staff of about 25 people that invents and makes critical cell culture technology that is enabling the field of T Cell Therapy to provide incredible results for cancer patients. They provide cancer patients with the real prospect of a cure with every device that we deliver.

Due to the high market response to their patented product portfolio, the company is experiencing 100% year over year growth in revenue and product demand. To scale accordingly, the company is implementing the Entrepreneurial Operating System of Traction, expanding into a 50,000 sq. ft. facility, and increasing the size and competencies of its staff.

They have engaged Talencio in the recruitment of a Quality Coordinator. They are seeking an individual that has a proven history of being a go-to person, routinely making others around them better, taking on hard challenges and making them look easy, and consistently rising to any occasion.


Reasons to Apply:


• You’ll be an instrumental part of a team that will play a critical role in providing society with
widespread access to T Cell Therapy, which many believe is one of the most important
advances in the history of cancer treatment.
• Wilson Wolf is highly profitable with no debt, and its liberal profit-sharing plan has paid out
an increasing amount of money for 4 consecutive years, providing employees at every level
of the organization with substantially higher compensation than they would have the
potential to earn elsewhere.
• This combination of meaningful work and potential for exceptional compensation is a rare
opportunity.
• Wilson Wolf’s founder has a strong track record, having already created two T Cell Therapy
companies with a combined value of $800M, one of which includes the 2018 Nobel Prize of
Medicine recipient.


Position Summary:


The Quality Coordinator is an energetic, quality focused, highly collaborative individual with experience in the medical device industry who will manage day-to-day documentation strategies, training, and activities to ensure compliance to medical device FDA QSR and ISO 13485 requirements.


Responsibilities include but are not limited to:


• Maintain Quality Calendar for time-sensitive activities including, but not limited to, activities
such as CAPA processes, Investigations, Internal & External Audits, Deviations,
Documentation Approvals, Training, Complaints, Approved Supplier Requalification,
Certificate Expirations (suppliers & internal), Renewals (FDA Establishment and Device
Listing – internal, Contract Manufacturer, Sterilization Facility), Process Monitoring,
Management Review, etc.
• Coordinate day-to-day quality assurance documentation activities to ensure compliance to
FDA QSR and ISO 13485 requirements.
• Plan and administer Quality Records management policies.
• Document Control (paper-based system)
• Assist with the author, change and update of quality system procedures, item specifications,
SOPs and forms; identify changes needed for existing documentation and processes to
support continuous improvement.
• Coordinate document revision processing (DCO’s), tracking, review, approval, distribution,
and archiving.
• Monitor, conduct and maintain employee training as required for quality system compliance.
• Administration and tracking of supplier quality management activities.
• Serve as a change agent, assisting associates company-wide with understanding and
adopting records management practices in alignment with recommended policies.
• Work collaboratively with staff to identify and resolve issues.
• Support maintenance of documentation and processes associated with the quality system,
including but not limited to: Nonconformities, CAPAs, Deviations, and Investigations.
• Ensure compliance with Federal, State and Local regulations through internal auditing of
processes.
• Maintain open, collaborative communication with associates.
• Assist as back-up for product and component inspection, as needed in cleanroom
environment or warehouse receiving.
• Suggest corrective and preventive actions to Quality management.
• Provide input for improvements to products, processes and quality system
• Report writing and PowerPoint presentation development, as needed.


Qualifications:


• Core values include the ability to exhibit professionalism, can-do attitude, makes those
around you better, and bring an A game daily.
• Minimum of 5 years solid, hands-on, direct medical device quality assurance experience
and document control management, including tracking quality metrics/trends in a FDA QSR
and ISO 13485 regulated medical device manufacturing environment.
• Minimum of 2 years of experience working in a small, developing organization, with a clear
understanding of the dynamics in a start-up environment; enjoys wearing “many hats” in a
small company culture.
• Technical college or bachelor’s degree in a scientific discipline.
• Knowledgeable about quality practices and procedures, including FDA Quality System
Regulations (QSR) and ISO 13485.
• Understanding and working with a paper-based documentation system.
• Computer skills with proficiency in MS Office applications (Word, Excel, PowerPoint) and
Adobe Acrobat; computer network organization are required with electronic data
management systems (eQMS) a plus.
• Clear proficiency at composition, reviewing and editing documentation; developing and
maintaining accurate tracking systems, and electronic and paper-based files.
• Proven ability to maintain attention to detail and organization while proactively organizing,
prioritizing, and executing multiple tasks.
• Experience with production inspections (incoming receiving, subassemblies, labeling, and
finished product), general measuring tools and test equipment, and maintenance and
calibration programs, desired but not required.
• American Society for Quality (ASQ) Certification is a plus.
• An energetic and collegial professional capable of identifying issues, as well as working
collaboratively to propose and implement solutions.
• Clear evidence of excellent written and verbal communication skills.
• Ability to clearly and professionally communicate with all levels of staff within the
organization.
• A strong ability to be self-driven and operate independently, demonstrating passion and
innovation for work goals and purpose.
• Energetic, versatile, and flexible.
• Solid, demonstrated ability to interact with a variety of audiences and understand their point
of view.
• Having a passion for embracing challenges, remaining focused on driving operational
improvements while remaining respectful of the stages of change that must occur within an
organization.
• Enjoys working in a small company culture which requires staff to participate in activities
outside of their normal job requirements.


Performance Measures:


• Timely execution of Quality Management System related activities and other assigned
tasks. This includes flexibility and addressing needs in a timely manner, collaborative
solving of problems, and an excellent grasp and command of operational and client quality
requirements.
• No citations of significant noncompliance by FDA, ISO Registrar, or customer auditors.
• Active participation in projects as an individual and as a team to achieve completion by
timeline and/or quality level. This includes identifying when it is necessary to bring in
reinforcements to achieve goals.


To apply, please send resume to amehlhoff@talencio.com.


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