Quality Manager

Posting Date: 05/09/2019
Closing Date: 06/10/2019
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 Manager. 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.


Job Purpose:
Reporting to the Senior VP of Regulatory Affairs & Quality Assurance, the Quality Manager will manage day-to-day quality assurance and quality control strategies and activities and ensure compliance to medical device FDA QSR and ISO 13485 requirements. This position will actively lead and collaborate with others within the organization as it relates to cross-functional product-related disciplines for new or modified products and processes.

Responsibilities include but are not limited to:
• Implementation and overall management of the quality management system (QMS) to
support Good Manufacturing Practices of Class I sterile medical devices ensuring high
productivity and high technical integrity.
• Ensure systems, policies and procedures are compliant with relevant standards and
regulations (ISO 13485:2016 and QSR).
• Achieve quality assurance operational objectives by contributing information and analysis to
strategic plans and reviews; prepare and complete action plans.
• Serve as liaison to Contract Manufacturing Organizations (CMOs) in topics including, but
not limited to, validation, manufacturing, quality engineering, and change control.
Coordinate response to issues throughout the organization.
• Establish, direct and monitor the implementation of departmental and staff objectives and
goals.
• Represent the organization on compliance matters related to facility inspections and quality
activities.
• Be responsible for product safety, complaint investigation and reporting as a result of
process changes, planned deviations, and/or recalls of GMP manufacturing, packaging
labeling and/or adverse events.
• Oversee quality design control staff and process, including the management of design
quality and process changes for prototyping, Research Use Only Products, and Finished
Products.
• Accept, hold or reject nonconforming components or product or otherwise assure from
unintended use.
• Provide design feedback regarding manufacturing robustness, including implementation of
error-proofing methods to minimize manufacturing errors.
• Approve Design Change Orders (DCO’s) on behalf of Quality.
• Coordinate validation and verification protocols, and final device master records for both
internal and external manufacturing processes.
• Facilitate and participate in risk management activities, including development of design,
process, and user FMEA.
• Ensure the training administration program is robust and employees are compliant to
training requirements, including providing training sessions as needed.
• Manage the control of suppliers through evaluation, approval, monitoring, auditing and
requalification programs.
• Manage the development of quality control plans for incoming components, in-process
manufacturing, and finished product release.
• Hire, supervise and manage diverse groups of associates.
• Drive the resolution of customer feedback, complaints, and investigations through the
organization.
• Maintain open, collaborative respectful communication with internal leadership and
associates.
• 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:
• Demonstrated success as a collaborative leader with the abilities to inspire and coach
others.
• Clear history of the ability to listen and understand others’ point of view and apply effective
negotiation skills to influence others towards a common goal.
• Solid, demonstrated ability to interact with a variety of audiences.
• Clear evidence of excellent written and verbal communication skills.
• Computer skills with proficiency in MS office applications (Word, Excel) and Adobe Acrobat;
computer network organization a plus.
• Analytical, clear proficiency with technical writing and editing; developing and maintaining
accurate electronic tracking systems, and electronic and paper files.
• Proven ability to maintain attention to detail while proactively organizing, prioritizing, and
executing multiple tasks.
• A reputation for being energetic and versatile demonstrating passion and innovation for
work goals and purpose.
• Being patient and remaining focused on driving operational improvements while remaining
respectful of the stages of change that must occur within an organization.


Qualifications:
• Bachelor’s degree in a scientific or engineering discipline.
• Significant Quality Engineering experience. ASQ CBA, CMQ/OE, CQA. CQE, CQM, CRE a
plus.
• 10+ years of solid, hands-on, direct medical device quality assurance senior management
in an FDA and ISO 13485 regulated medical device manufacturing environment
successfully leading and mentoring others and driving continuous improvement.
• 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, procedures and standards, including Quality
System Regulations (QSR), ISO 13485. European Medical Device Regulation (EU MDR) a
plus.
• Experience with production inspection (incoming receiving, subassemblies, labeling,
finished product); general measuring tools and test equipment, maintenance and calibration
programs; problem solving and resolution.
• Knowledge of industrial safety regulations.
• Enjoys a variety of work in a fast-paced, startup environment.













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



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