Senior Quality Control 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 Senior Quality Control 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 Senior Quality Control Engineer is responsible for overseeing day-to-day quality control activities, assisting inspectors and manufacturing personnel to overcome challenges faced while meeting production goals. This individual ensures compliance with quality system procedures and processes in the cleanroom and other manufacturing spaces. 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:


• Implement the Quality Management System for production and process controls.
• Proactively suggest and implement process improvements. Following are activities of
direct oversight: Receiving; incoming inspection; release of goods, In-process and finished
product inspection, Equipment installation and validation, Device History Records.
• In conjunction with manufacturing engineering, develop process validation planning,
execution and reporting.
• Coordinate with manufacturing and QC personnel with the generation and completion of
Nonconforming Material Reports (NCMR), Deviations, Corrective/Preventive Action
(CAPA)s, complaint investigations; Supplier Corrective Action Reports (SCAR); Returned
Material Goods Authorization (RMA).
• Manufacturing and test equipment maintenance and calibration - manage equipment
standards program, write new standards, oversee repairs, schedule service, maintenance &
calibration activities.
• Monitor, track, trend data for technical and management reviews (e.g., product and test
method monitoring and measurement, deviations, NCMR trends).
• Support risk management activities and process FMEA analysis.
• Participate in auditing activities as required, including internal auditing to meet regulatory
requirements.
• Prepare technical materials for Management Review meetings.
• 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:


• Minimum 10 years relevant experience in a regulated medical device manufacturing
environment.
• Experience in a dynamic medical device manufacturing environment with varied technical
product mixes.
• Extensive knowledge of sterile product manufacturing & quality assurance, including
gamma irradiation sterilization validation.
• Bachelor’s degree in STEM field (science, technology, engineering, mathematics), or
demonstrable equivalent experience.
• Self-starter and motivated individual who works collaboratively with other technical team
members.
• Ability to work on long-term projects with clarity, vision and determination.
• Analytical problem-solving skills with a demonstrated ability to resolve complex issues.
• Computer literacy in MS Office – Word, Excel, Outlook and PowerPoint.
• Ability to collect, summarize and report technical information.
• Excellent verbal, interpersonal and written communication skills.


Helpful Qualifications:


• Direct experience implementing QSRs and ISO 13485-compliant processes in a
manufacturing environment.
• Strong technical report writing.
• Basic statistical analysis and interpretation of statistical data (i.e., SPC, population testing,
confidence intervals).
• Direct experience in product transfer teams.
• American Society for Quality certification (e.g., CQE, CQA, CBA,).



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


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