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Quality Systems Specialist in Kenosha, WI at Tecomet

Date Posted: 3/21/2019

Job Snapshot

Job Description

LEADING MEDICAL DEVICE MANUFACTURER NEEDS TOP-NOTCH QUALITY SYSTEMS SPECIALIST!

Tecomet, Kenosha, WI, is one of the leading contract manufacturers of medical implants and surgical instruments in the United States. Quality is number one within our organization and it is our team of dedicated and highly skilled teammates that put us at the forefront!

It is an exceptionally exciting time to join Tecomet as we grow our organization through the recruitment of great team member candidates.   Our Kenosha manufacturing plant, conveniently located between Chicago and Milwaukee, and within 1-2 miles of the expressway might be the right fit for you.  

Here at Tecomet, we value employee excellence. We offer a competitive compensation package, including great benefits with no waiting period to enroll.

Join one of the top contract medical device manufacturers in the U.S.--join Tecomet!

POSITION SUMMARY

This position will work closely with Quality Engineering and members of the CFT. The Quality Systems Specialist has a structured plant-wide approach to training and document control for the Kenosha plant. This person will also be responsible for the maintenance and development of key quality systems as assigned.  This will include continuous assessment of employee development needs for all positions, as well as the development, implementation and evaluation of training efforts to align with business strategy.  The individual will develop, coordinate, implement, and communicate training initiatives and document control activities to ensure the facility is compliant and auditable. He/she will also manage the document control system to ensure documentation procedures are maintained based on FDA/ISO and Corporate standards and regulations.

The scope of the job will also include supporting the setup of new products, product extensions and product revisions. The role will require day to day quality technical support to the Quality System Technicians for tasks such as setting up inspection criteria, control plans, FMEAs, labelling, customer complaints, tracking and trending, etc.

PRINCIPAL RESPONSIBILITES

  • Researches, plans, organizes, and supports the needs of Kenosha training programs through coordination, instruction and monitoring of effectiveness.

  • Collaborates with management, supervisors and employees to gain knowledge of work situations requiring training and to better understand changes in policies, procedures, regulations, business initiatives and technologies.

  • Designs, conducts and drives training orientation, and tracks and reports on progress of employees under guidance during training periods (i.e. QSRs, JTAs).

  • Maintains employee training records and matrix and reports training information as subject matter expert to internal and external customers/auditors upon request.

  • Researches, writes material, selects or develops training aids and establishes measures of effectiveness for new training programs; reviews, evaluates, and modifies existing and proposed programs and recommends appropriate changes.

  • Manages the document control system in order to meet and maintain FDA/ISO and Corporate standards and regulations.

  • Executes the change control process for product and process related information, providing records and information management services to various departments.

  • Manages the overall direction for the creation and updates of product and process-related data in accordance with internal procedures, FDA regulations, and ISO requirements.

  • Supports internal and external audit activities through retrieval and provision of requested document and data elements in a timely matter.May act as subject matter expert related to Records and Information Management activities, interfacing with auditors as required.

  • Continuously improves current business and system processes by creating, redefining, and maintaining standard operating procedures (SOPs) to ensure maximum efficiency..Seeks input on improved strategies and processes to implement and achieve goals.

  • Responsible for the organization, maintenance and storage of all documents related to FDA/ISO compliance, DMRs, DHRs, DCNs, and Management Review Records.

  • Maintains established metrics and achieves goals for the document control system, including document entry, approval and required training.

  • Assists Quality Engineering with the development of control plans and FMEA’s.
  • Provides guidance for inspection methods, criteria, harmonization, and measurement system analysis. 
  • Interprets engineering drawings and specifications in order to develop and maintain inspection criteria.
  • Interacts with the Customer to assure timely completion of required activities.
  • Participates in team meetings and provides updates on action items.
  • Learns, understands, and applies task-specific computer applications associated with assigned duties.
  • Assists in creating Master Labels for approval - internal and customer.
  • Assists in creation, maintenance, and review of label requests.
  • Assists Quality System Technicians as needed with the RMA & Complaint process.
  • Additional functions and requirements may be assigned by supervisors/managers as necessary.

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES:

  • Quality System Regulation and ISO13485 knowledge base.
  • Experience in the area of manufacturing operations.
  • Thorough knowledge of English and metric dimensioning.
  • Understanding of Gage R&R.
  • Knowledge of GD&T
  • Understand the importance of ISO and Quality System Requirements (QSR) in manufacturing environments.
  • Understand and implement continuous improvement techniques on projects.
  • Possess dexterity and preciseness required to operate gauges and testing equipment.
  • Ability to follow written and verbal instructions.
  • Commitment to the growth and continuous improvement of the company and its employees.
  • Participate in Quality improvement projects as necessary to support the company goals and strategic business plan.
  • Must be capable of making decisions and being assertive in a professional way, appropriate for a growing customer-focused and employee-sensitive business environment.
  • Must be professional, conscientious, responsible, dependable, flexible, and proficient with good work habits, close attention to detail, strong workmanship and a positive attitude.
  • Must also be able to work independently and be capable of meeting deadlines.
  • Computer literacy.
  • Problem solving skills.
  • Good oral and written communication skills

EDUCATION AND EXPERIENCE:

  • High school diploma or equivalent required
  • Degree desired but not required
  • ASQ Certification preferred
  • Minimum 2 - 3 years Quality Assurance experience preferred
  • Metrology-related experience desired

PHYSICAL DEMANDS

While performing the duties of this job the employee is frequently required to stand, sit, walk, talk, and hear. The employee is occasionally required to reach with hands and arms, stoop, kneel, or crouch.

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.

MISCELLANEOUS:

The duties listed above are intended only as illustrations of the various types of work that may be performed.  The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position.

The job description does not constitute an employment agreement between the employer and the employee and is subject to change by the employer as the needs of the employer and requirements of the job change.