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
• 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
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,
• 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
• 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.
• 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
• 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
• 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
• Enjoys working in a small company culture which requires staff to participate in activities
outside of their normal job requirements.
• 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
• 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 email@example.com.