I.  POSITION SUMMARY

 

This position is responsible for product quality analysis, disposition, and corrections.  This may be done through various quality systems such as customer complaints, non-conformance reporting, and inspections.  Interacts with personnel at manufacturing sites to conduct and document appropriate investigations.  The person is this role may own quality management systems at the site which includes responsibilities for workflow management, metrics, training of support personnel and reporting up through management review.  The person in this position must comply with the applicable regulations pertaining to the site such as FDA QSR, ISO 13485, CMDR, and any additional MDSAP regulatory requirements that pertain to the site.

 

 

II.  MINIMUM KNOWLEDGE, EDUCATION AND SKILL REQUIREMENTS

Associates Degree or equivalent work experience.

3+ years’ experience with Quality Systems in a distribution/logistics environment or equivalent work experience.

Familiarity with FDA/QSR and/or ISO Quality System Requirements.

Computer proficiency, experience with common application programs – word processing, database, and spreadsheets, required.

Experience with SAP preferred.

Familiarity with the KARL STORZ line of products preferred.

 

 

III.  ESSENTIAL FUNCTIONS

A.  PHYSICAL REQUIREMENTS

                                   

Must be able to work overtime as needed.

Must be punctual, able to sustain attendance guidelines, and work hours as assigned.

The incumbent will work in a typical office environment. May need to spend significant amount of time in operational areas.

Eyesight sufficient to make judgments on identification and visual quality of product.

Must be able to spend lengthy amount of time at computer creating/searching for information.

Requires physical movement of product with actions such as moving, reaching, grabbing, packing, lifting, stacking, pulling, and pushing.  Position requires occasional heavy lifting, up to 40 lbs.

 

B.   MENTAL REQUIREMENTS

 

Position requires good judgment and decision making skills.

Position requires excellent attention to details.

Must be capable of making accept/reject decisions based on established procedure and criteria.

Must be able to recognize and bring to supervisory attention situations which may impact quality but which are not covered in established procedures.

 

C.  DUTIES AND RESPONSIBILITIES  (Other duties consistent with the general nature and focus of the position and/or the goals and objectives of the department may be assigned.)  One or more of the following responsibilities may be assigned at any particular time based on business needs.

 

Work to ensure processes are compliant with FDA/QSR and ISO Requirements.

Support quality management systems at the site which includes responsibilities for workflow management, metrics, training of support personnel and reporting up management review

Author procedures to clearly and effectively document processes.

Support and assist other departments in the creation of documented procedures.

Ensure compliance to established document control procedures.

Support all document changes per established procedures.

Provide final review and edit before release of documents.

Review documentation to ensure established processes, methods, and standards are being followed.

Support Change Review Board meetings.

Release all documentation such as drawings, specifications, procedures, work instructions, quality reports, and forms per established procedures.

Support training matrix and individual QSR training records.

Ensure compliance to established Record Retention procedures and maintain and coordinate off-site record files.

Maintain document hard copy library and reference center.

Maintain numbering system for all levels of controlled documentation.

Process requests for documents and change request number assignments.

Maintain labeling, manual, and insert reference library.

Review track open change requests for compliance to time limit requirement.  Notify requestor of failure and need to re-issue change request.

Responsible for accuracy of all work, for processing documentation releases and changes in a timely manner, and for reporting quantity of change requests / orders and document releases processed on a monthly basis.

Complete complaint investigations as assigned.

Non-conformance coordination, review, investigation, and disposition.

Perform inspections on product related to complaint and non-conformance investigations.

Support periodic review of all documentation to ensure they accurately reflects current processes.

Maintain system for calibration of testing and measuring equipment.

Ensuring that all Regulatory and Quality requirements are followed as documented.  This will require that the incumbent periodically monitor quality processes by attending meetings, reviewing work results, and completing spot audits.

Auditing forms and reports for compliance

Ensuring that product(s) on complaints, quality/regulatory holds, and re-inspects are processed in a timely manner with proper documentation.

Ensuring that KSEA Regulatory is notified of all Quality Holds issues immediately.

Support ensuring that all requests submitted to the Quality department are communicated and successfully resolved or transferred to the correct departments for resolution.

 

D.  SAFETY:

 

Must not pose a direct threat or significant risk of substantial harm to the safety of himself/herself or others.

Must be committed to a high standard of safety and be willing and able to comply with all safety laws and all the Company’s safety policies and rules.  Must be willing to report safety violations and potential safety violations to appropriate supervisory or management personnel.

Responsible for informing the Company if he/she is taking medications or if there are any other circumstances that would interfere with safe performance of job duties.

 

E.  QUALITY

 

The incumbent in this position is generally responsible for following FDA/QSR guidelines as described in the procedures related to his/her specific job responsibilities.

   

F.  INTERPERSONAL AND COMMUNICATION SKILLS

 

Must be able to maintain productive working relationships with co-workers.

Must treat fellow employees with respect.

Good grammatical skills are required to proof read, edit, and/or write procedures in clear, concise language.

Will interact with all levels of the organization to communicate needs and relay information to KARL STORZ employees located at multiple locations.  May also interact with external customers and suppliers.  This will require effective written and oral communication skills.

Must be able to adapt and demonstrate flexibility in dealing with changing priorities and work situations.

Must demonstrate motivation and initiative.

 

 

IV.  OTHER FUNCTIONS

 

A. OTHER DUTIES AND RESPONSIBILITIES (Other duties consistent with the general nature and focus of the position and/or the goals and objectives of the department may be assigned.)

 

Serve as a point person for problem solving and answering questions.

Assist with management review meetings.

Review labeling text revisions and new issues from Regulatory Affairs for obvious errors.

QSR Documentation Change Review Board.

Process change reviews.

Corrective and Preventive Action.

Conduct Internal Audits as part of the internal audit team.

Software revision control and tracking.

Problem resolution.

Other duties as assigned.

  

B.  OTHER PHYSICAL, MENTAL, INTERPERSONAL AND COMMUNICATION REQUIREMENTS

 

Communicates with manufacturers to conduct appropriate product investigations.

Communicates with customers as needed to obtain information for complaint investigations