MinneapolisRecruiter Since 2001
the smart solution for Minneapolis jobs

Quality Manager

Company: Wilson Wolf Manufacturing Corporation
Location: Minneapolis
Posted on: June 26, 2019

Job Description:

Title:----------------------------------------------------------------------Quality ManagerReports to:--------------------------------------------------Sr. VP of Regulatory Affairs & Quality AssuranceDepartment:--------------------------------------------Quality--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. We provide cancer patients with the real prospect of a cure with every device that we deliver.--Due to the high market response to our 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.----We are seeking a Quality Manager 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 to 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:Wilson Wolf Corporation is a privately-held medical device design and manufacturing company seeking an experienced Quality professional who 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.Provide design feedback regarding manufacturing robustness, including implementation of error-proofing methods to minimize manufacturing errors.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.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.Other responsibilities as needed to drive excellence and the success of the business.Perform other related duties or special assignments as assigned.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.Resources:Wilson Wolf personnel working in a collaborative mannerConsultantsWilson Wolf Quality Management SystemPublished standards and guidancePrevious education and work experienceProfessional organizationsWilson Wolf Officers, Managers and other personnel as required------------------------Preferences:Preference will be given to applicants that are within driving distance from the Twin Cities

Keywords: Wilson Wolf Manufacturing Corporation, Minneapolis , Quality Manager, Executive , Minneapolis, Minnesota

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Executive Jobs


Director of Nursing /Clinical Administrator - Assisted Living (AL)
Description: OverviewPresbyterian Homes Services is seeking a Director of Nursing / Clinical Administrator to join our Assisted Living team at SummerWood of Chanhassen. This community serves through options in Independent (more...)
Company: Presbyterian Homes & Services
Location: Chanhassen
Posted on: 07/23/2019

Business Development Director
Description: Description: br Position Summary br The Business Development Director position is a key sales role within the Our Client's Life Sciences Unit sales team for North America, responsible for executing (more...)
Company: Tephra Inc.
Location: Minneapolis
Posted on: 07/23/2019

Marketing Director
Description: SUMMARY: Responsible for the development, implementation and management of the overall advertising and marketing strategy for Treasure Island Resort Casino, consistent with the organizational objectives. (more...)
Company: Treasure Island Resort & Casino
Location: Red Wing
Posted on: 07/23/2019


11B Infantryman - Management Training
Description: 11B Infantryman - Management Training Job ID: 1084138 Job Views: 31 Location: NEW RICHMOND, Wisconsin, United States ZIP Code: 54017 Job Category: Ground Forces Posted: 07.19.2019 Age Requirements: Must (more...)
Company: Army National Guard
Location: New Richmond
Posted on: 07/23/2019

Lead Case Manager
Description: Overview City: Minneapolis State: MN Country: United States of America Category: Human Services Employment Status: Full Time Description Lutheran Social Service MN is a dynamic social service organization (more...)
Company: Lutheran Social Service of MN
Location: Minneapolis
Posted on: 07/23/2019

11B Infantryman - Management Training
Description: 11B Infantryman - Management Training Job ID: 1079385 Job Views: 16 Location: EAST SAINT PAUL, Minnesota, United States ZIP Code: 55106 Job Category: Ground Forces Posted: 07.19.2019 Age Requirements: (more...)
Company: Army National Guard
Location: Saint Paul
Posted on: 07/23/2019

Housekeeping Manager
Description: Housekeeping Manager SUMMARY: To plan, organize, and direct the activities of the casino Environmental Service operations ensuring the casino complex is clean and sanitary. Responsible for a high level (more...)
Company: Treasure Island Resort & Casino
Location: Red Wing
Posted on: 07/23/2019

Housekeeping Manager
Description: Housekeeping Manager SUMMARY: To plan, organize, and direct the activities of the casino Environmental Service operations ensuring the casino complex is clean and sanitary. Responsible for a high level (more...)
Company: Treasure Island Resort & Casino
Location: Prescott
Posted on: 07/23/2019

Senior Project Manager
Description: Job DescriptionAbility to lead and manage projects inside construction settingsProvide professional leadership in negotiation and problem resolution
Company: Michael Page
Location: Minneapolis
Posted on: 07/23/2019

Housekeeping Manager
Description: Housekeeping Manager SUMMARY: To plan, organize, and direct the activities of the casino Environmental Service operations ensuring the casino complex is clean and sanitary. Responsible for a high level (more...)
Company: Treasure Island Resort & Casino
Location: Lake City
Posted on: 07/23/2019

Log In or Create An Account

Get the latest Minnesota jobs by following @recnetMN on Twitter!

Minneapolis RSS job feeds