Quality Assurance/Quality Management Systems Engineer

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 they 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 Assurance/Quality Management QA/QMS Engineer. They are seeking an individual with 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

Reporting to the Quality Management Director, the QA/QMS Engineer is responsible for overseeing day-to-day quality assurance activities related to new product development and the quality management system. This position is key to ensuring quality systems run smoothly and remain in compliance with regulatory requirements (FDA, ISO 13485). This individual ensures compliance with quality system procedures and processes in the engineering and business groups. This individual works collaboratively with engineering and manufacturing to develop processes and procedures that improve Wilson Wolf and meet the Company’s goals.

Responsibilities include but are not limited to:

• Author, change and update quality management system (QMS) procedures and working
documents to ensure compliance to FDA QSR and ISO 13485:2016 requirements.
• Actively participate in design teams, including creating test protocols, participating in risk
management activities and reviews, and running and documenting testing as required.
• Collaborate with engineering to define material specifications and documentation packages.
• Manage the Approved Supplier program by meeting with and reviewing potential and
current suppliers to assess their capabilities. Ensure suppliers are evaluated, approved,
and monitored according to procedures, including conducting supplier quality audits.
• Be a designated Complaint handler and actively drive investigations; remain vigilant in the
status of all situations, and actively drive appropriate response measures for final
determination and corrective action.
• Participate in auditing activities, including internal auditing to meet regulatory requirements;
external auditing by regulatory authorities and customers; and supplier audits.
• Manage all aspects of CAPA activity including gaining the commitment of cross-functional
resources, scheduling CAPA team meetings, driving investigations, and ensuring CAPA
deliverables with verification of effectiveness.
• Prepare technical materials for Management Review meetings.
• Perform other related duties or special assignments as assigned.
• Update job knowledge by studying trends and developments in quality management,
participate in educational opportunities, read professional publications, maintain personal
networks, and participate in professional organizations.

Skills:

• Strong communicator. Clear evidence of excellent written and verbal communication skills.
• Problem solver. As an action-oriented self-starter, able to diagnose inefficiencies,
determine root causes, and recommend solutions to complex challenges.
• Organized. Proven ability to maintain attention to detail while proactively organizing,
prioritizing, and executing multiple tasks.
• Personable. Can establish and nurture highly effective relationships with a variety of
audiences - colleagues, customers, and suppliers.
• A strong reputation for the ability to be self-driven and operate independently, energetic,
and demonstrating passion and innovation for work goals and purpose.

Essential Qualifications:

• 5+ years of solid, hands-on, direct medical device quality assurance experience in an FDA,
QSR and ISO 13485 regulated medical device manufacturing environment.
• Bachelor’s degree in STEM field (science, technology, engineering, mathematics), or
demonstrable equivalent experience.
• Significant Quality Engineering experience. ASQ CQA or CBA a plus.
• A minimum of 2 years of experience working in a small, developing organization, with clear
understanding of the dynamics in a privately held, small company environment.
• Firm understanding of quality practices and procedures, including Quality System
Regulations and ISO 13485: 2016.
• Computer skills with proficiency in MS office applications (Word, Excel, PowerPoint) and
Adobe Acrobat; computer network organization a plus.
• Enjoys a variety of work in a fast-paced, startup environment.

Helpful Qualifications:

• Experience implementing online quality management systems (e.g., Grand Avenue).
• Experience in organizational activities to achieve ISO 13485 certification.
• Direct experience in product transfer teams.
• American Society for Quality certification (e.g., CQE, CQA or CBA)



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


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