• Job Description

  Req#: R016354

  About Us:

  Machine Solutions is the premier provider of advanced equipment and services for the medical device, biopharmaceutical, and blood- and plasma-collection industries. We support our customers’ needs and growth by delivering quality and value through a wide breadth of products. Machine Solutions provides proprietary mechanical solutions to a variety of complex process, testing and device design challenges. Our equipment has become the industry standard for stent crimping, balloon catheter pleating and folding, catheter braiding and medical device manufacturing applications. As a pioneer in radio frequency technology, the company has continued to develop advancing technology for thermal forming, molding and welding plastic for medical manufacturing, biopharmaceutical, and blood- and plasma-processing applications. Our experienced team of engineers has been instrumental in automating manual processes that enable our customers to increase production volumes and profit margins, and we believe in providing a superior customer experience by designating resources to a dedicated aftermarket team that is always ready to provide technical service and process support. Machine Solutions is privately owned by BW Forsyth Partners, a Barry-Wehmiller company.

  
  

  BW Forsyth Partners is the investment arm of multibillion-dollar global manufacturing and engineering consulting firm Barry-Wehmiller. Established in 2009, BW Forsyth Partners blends Barry-Wehmiller’s unparalleled legacy of value creation and people-centric culture development with keen investing experience to help companies realize their true potential. With a focus limited to areas known well, BW Forsyth Partners seeks to partner with leadership teams to acquire small- to middle-market companies in the capital and component equipment, and professional services sectors. In each of our operating companies, BW Forsyth Partners deploys operational improvements and strategy development without compromising the autonomy, strategic vision and entrepreneurial spirit of their leadership teams.

  
  

  Job Description:

  Vante/Machine Solutions

  Job Description

  Job Title: Quality Leader

  Reports To: VP, People and Quality

  Salary Range: $90,000.00-$120,000.00 Annually

  Position Responsibilities

  • Supervises master document control programs and quality specialists using GMP’s and established design standards.
  • Accepts high level responsibility for the control of product design documentation, ensuring the accuracy and completeness of such documents defined in Vante’s quality system and established practices.
  • Manages the Quality System to ensure compliance with ISO 9001:2015 standards, and to prevent and eliminate product defects.
  • The implementation and coordination of organizational control activities as required in the Quality Manual.
  • Assist, initiate, and maintain inspection and testing standards, methods, and procedures for each of incoming, first article, in-process, final, and repair status of products. Evaluate inspection/test data and generate reports indicating compliance with, or deviation from, existing standards.

  • Regulatory Affairs- Head of Quality acts as management representative/corporate liaison for regulatory agencies such as the ISO 9001:2015 registrars. In conjunction with Engineering Leader ensures that various regulatory requirements are implemented, followed, and effectively maintained as well as remains abreast of technical, safety and regulatory changes in the industry by consulting outside regulatory experts, regulatory agencies, and reviewing journals, publications, and articles.

  Position Tasks

  • Coordinate all quality functions and personnel within the company including preparation of quality plans; maintenance of the company Quality Manual and supporting procedures; identification and acquisition of controls, processes, inspection equipment, skills, and resources needed to achieve the required quality; clarification of workmanship standards; compatibility of all processes and supporting documentation; and identification and preparation of quality records.
  • Supervises associates engaged in inspecting and testing products or recording data concerning all product assembly levels and functions.
  • Supervises Master Document control and Quality Specialists and Technicians. Trains and coaches team members on QMS and associated objectives. Supports engineering, R & D, quality assurance, production, marketing, management, and others on all Quality related processes.
  • Implements effective procedural documents and training programs for individuals from varied cultural and educational backgrounds. Determining and performing the proper level of Quality System and Standards training for a diverse group of individuals.
  • Coordinates with department heads individual QMS training requirements and present technical instruction to employees for training in internal auditing skills and knowledge, quality policies and procedures, and ISO 9001:2015 standards.
  • Participates with management and department heads in formulating and establishing company policies, operating procedures, and goals.
  • Review technical problems and departmental procedures, recommending solutions to problems or changes in procedures to remain compliant with required regulations.
  • Assist in identification, prioritization, and selection of potential projects in all functional areas of the business to optimize processes and ensure quality is built into all aspects of the product design and manufacturing.
  • Contributes to the evolution, maintenance, and improvement of Vante’s use of the ERP system software.
  • Trains department members on system use and application. Lead root cause analysis and implement corrective actions and appropriate countermeasures to identified issues.
  • Other duties may be assigned.

  QUALIFICATION REQUIREMENTS

  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  EDUCATION AND/OR EXPERIENCE

  Bachelor’s degree or equivalent preferred; or, a minimum of five years related experience and/or training; or, an equivalent combination of education and experience with an emphasis in receiving, product inspection, measurement and testing, analysis, tracking design, and management. Five years management or supervisory experience, and Quality Control/Assurance and manufacturing experience. Preferred experience includes three years’ experience in each of Safety/Environmental, electronics manufacturing, engineering support, and quality.

  SPECIAL REQUIREMENTS

  Individual must be highly credible, self-motivated individual with strong work ethic. Must demonstrate a successful track record where personal goals and objectives are consistently and reliably met.

  Must be able to complete tasks in a timely manner and work on multiple projects at the same time.

  LANGUAGE SKILLS

  Ability to read, analyze and interpret common scientific, business, or professional journals, technical procedures, government documents, financial reports, regulatory standards, and legal documents. Ability to effectively present information and respond to questions from top management, customers, suppliers, and employees. Ability to write reports, business correspondence and procedure manuals.

  MATHEMATICAL SKILLS

  Ability to apply concepts such as fractions, percentages, ratios and proportions to practical situations. The ability to work with mathematical concepts such as the fundamentals of statistics, probability, geometry and trigonometry. The aptitude to adapt mathematical concepts to computer software.

  REASONING ABILITY

  Ability to define problems, collect data, establish facts, and draw valid conclusions with recommendations for resolution. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Ability to deal with a variety of abstract and concrete variables in situations where limited standardization may exist.

  PHYSICAL DEMANDS

  The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  While performing the duties of this job, the employee is frequently required to sit. The employee is occasionally required to talk or hear; stand; move; and use hands to finger, handle or feel small objects, keyboards, tools, or controls. The employee must occasionally lift and/or move up to 40 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

  WORK ENVIRONMENT

  The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  #LI-SR1

  
  

  At Barry-Wehmiller we recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job. If your experience is close to what you see listed here, please still consider applying. We know that our differences often can bring about innovation, excellence and meaningful work—therefore, people from all backgrounds are encouraged to apply to our positions. Please let us know if you require reasonable accommodations during the interview process.

  Barry-Wehmiller is an equal opportunity employer. M/F/D/V This organization uses E-Verify.

  
  

  Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments.

  
  

  Company:

  Machine Solutions, Inc.

• About the company

  Barry-Wehmiller Companies is a global supplier of manufacturing technology and services based in St.

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