2 days old

Quality System Specialist

Handicare USA, Inc.
St Louis, MO 63103





















JOB TITLE:


QUALITY SYSTEM SPECIALIST


DEPARTMENT:


QUALITY


REPORTS TO:


Sr Quality & Regulatory Manager


FLSA STATUS:


EXEMPT




 



OVERVIEW:  The Quality System Specialist is responsible for the implementation and maintenance of effective


Quality Systems in accordance with FDA Quality Systems Regulation, ISO 13485 and other applicable country specific regulations.


 


ESSENTIAL DUTIES AND RESPONSIBILITIES:



  • Inspect incoming mechanical and electrical components, assemblies, material, PCBs, labels, packaging to drawings and specifications following AQL sampling plans.

  • Inspection and testing of in-process & finished medical devices to documented Work Instructions as needed.

  • Accurate record keeping of all inspection data.

  • Documentation of quality related issues per established procedures and work instructions.

  • Quarantine, or segregation of nonconforming material and disposition accordingly per documented procedures.

  • Perform status movement changes in ERP system.

  • Develop recommendations for improvement based on data collection of received goods from supply base.

  • Inspect final assemblies of ceiling lifts, floor lifts and accessories per determined sampling plans to ensure they meet the specifications outlined in the work instructions.

  • Perform routine audits of final assembly to determine compliance with work instructions and quality system requirements.

  • Report any defect, quantity or receipt error immediately to the Production/Quality Engineer.

  • Document quality related issues (i.e.:  NCR etc.) per established procedures and work instructions.

  • Provide quality metrics on final assembly processes.

  • Participate in Corrective and Preventive Actions in order to improve internal quality processes.

  • Participate in the development of Work Instructions used to manufacture Handicare equipment.

  • Develop, implement, maintain and monitor quality metrics for the facility.

  • Document quality systems and programs in quality trends, training, corrective and preventive actions, process control, customer complaints, etc. to ensure compliance with FDA, and regulatory requirements.

  • Ensure corrective actions implemented are effective by verifying that repeat failures are eliminated.

  • Participate in regulatory inspections, ISO audits and customer audits.

  • Support the Internal Audit Program.  Participate in internal audits per schedule and review the results of all audits to ensure resolution of any noted deviations.

  • Management of Staff (Quality Inspectors) and Quality raw materials / final products, ensuring the processing of conforming product and the resolution of non-conforming materials.

  •  Crossed trained in all three areas of inspection.

  • Managing process improvements with Engineering, Procurement and Suppliers.

  • Support manufacturing activities as needed.

  • Additional duties as requested or required.



 


 


SUPERVISORY RESPONSIBILITIES:



  • This position has supervisory responsibilities.



COMPETENCIES:



  • Speaks clearly and persuasively in positive or negative situations.

  • Writes clearly and informatively

  • Edits work for spelling and grammar

  • Looks for ways to improve and promote quality

  • Demonstrates accuracy and thoroughness

  • Understands business implications of decisions

  • Follows policies and procedures

  • Follows instructions, responds to management direction

  • Observes safety and security procedures

  • Determines appropriate action beyond guidelines



LANGUAGE SKILLS:



  • Ability to read, analyze and interpret general business periodicals, professional journals, safety rules, technical procedures or government regulations.  Ability to write reports, business correspondence and procedure manuals.  Ability to effectively present information and respond to questions from group of managers, clients, customers and the general public.



EDUCATION, EXPERIENCE & TRAINING:



  • High School Diploma or general education degree (GED); and 2 to 3 years of quality assurance experience; preferably in a manufacturing environment; or equivalent combination of education and experience.



CERTIFICATES, LICENSES OR REGISTRATIONS:



  • None required.  Quality Assurance certification preferred.



COMPUTER SKILLS:



  • Proficiency in Microsoft Word, Excel, PowerPoint and Outlook is required.  Intermediate proficiency with statistical software packages, such as MiniTab is preferred.



PHYSICAL DEMANDS:  



  • The employee may occasionally stand, walk, stoop, kneel or crouch during shift.  Employee will be required to regularly sit, use hand to finger, handle, feel and reach with hands and arms.  Employee must be able to occasionally lift, push, pull and or move up to 50 lbs.



WORK ENVIRONMENT:



  • This position works in an environment with moderate noise levels.



TRAVEL:



  • This position may travel up to 25% of the time.



 


EOE/M/F/D/V


 


Note: Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time.  Critical features of this job are described under various headings above.  They may change at any time due to reasonable accommodations or other reasons.  The above statements are strictly intended to describe the general nature and level of the work being performed.  They are not be construed as a complete list of all responsibilities, duties and skills requires of employees in this position.   The physical demands described here are representative of those that must be met by an employee to successfully perform the essential duties of the job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


 


I have read and understand the duties of my position:


 


Print Name: _____________________________________            Date: ___________________________


Signature: _______________________________________

Categories

Posted: 2021-10-16 Expires: 2021-11-15

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Quality System Specialist

Handicare USA, Inc.
St Louis, MO 63103

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