Less than 1 hour

Sr. Quality Engineer

Handicare USA, Inc.
St Louis, MO 63103





















JOB TITLE:


Sr. Quality Manager


DEPARTMENT:


Quality


REPORTS TO:


Quality Director & VP Global Quality & Regulatory Affairs


FLSA STATUS:


Exempt




 



OVERVIEW:



  • To build, develop, organize, and manage the companys quality team and oversee US quality programs by analysing data; identifying and driving improvements to further enhance the quality, environmental and health and safety performance of the business processes for new and existing products in the patient handling business. 



ESSENTIAL DUTIES AND RESPONSIBILITIES:



  • Act as a change agent for the rapid evolution from a quality control to a quality assurance structure.

  • Strong leadership and coaching skills at all levels of the organization. 

  • The drive and energy to lead transformative change in the way we approach quality, building quality expectations into processes and design.

  • Prior experience in manufacturing of medical device quality systems

  • To build and develop a new quality team focused on identification of issues and root causes, addressing them, and delivering permanent improvement. Coaching them to continually improve themselves and the business.

  • Manage and facilitate corrective and preventive actions required for QHSE, ensuring all product related issues, customer complaints/accidents, incidents etc., driving through to closure.

  • Establish automated reporting on performance against KPIs and regulatory reporting for QHSE.

  • Administer and support, including regulatory reporting the established group policy for the FDA and EHS certifications as well as applicable statutory reporting for the KWF site e.g. FDA, HSE, the Environment Agency etc.

  • Take the lead in any complex investigations as appropriate.

  • Ability to analyse data and information, both numerical and anecdotal to determine plan of action and carry it out.

  • As the company representative implement and maintain the companys Business Management Systems ensuring compliance to ISO9001, 14001, OHSAS 180001/ISO 45001 and ISO 13485 and FDA QSR requirements as appropriate.

  • To locally implement and monitor Group QHSE Policies and Processes.

  • Lead and manage the internal audit program, conduct internal audits and drive associated improvement activity.

  • Assist in new product introduction from design stage through to production.

  • Assist in the management of new and existing suppliers, including performance and supplier audit, and supplier control.

  • Ensure, through the team, legal compliance at the KWF for QMS/EMS and H&S.



 


COMPETENCIES:



  • NEBOSH

  • Knowledge of quality systems related to medical devices FDA/ISO 13485 or other highly regulated industry.

  • Knowledge of EH&S systems and legal requirements

  • Good IT skills

  • Strong engineering (ideally electromechanical) background and education

  • Lead auditor qualification

  • Excellent interpersonal skills at all business levels

  • Good presentation & communication skills

  • Great prioritising and managing high workload.

  • Analysing and interpreting data and good reporting skills



 


LANGUAGE SKILLS:



  • Ability to read, analyze and interpret documents such as safety rules, operating and quality instructions and procedural manuals.   Ability to write reports and correspondence.   Ability to speak effectively before groups of customers or employees of the organization.



EDUCATION, EXPERIENCE & TRAINING:



  • Associates degree (A.A) or equivalent from a two-year college or university and 5+ years of manufacturing experience, along with 5 years of supervisory experience; or equivalent combination of education and experience.



CERTIFICATES, LICENSES OR REGISTRATIONS:



  • ASQ Certification required.

  • Six Sigma Black Belt certification preferred.



COMPUTER SKILLS:



  • Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook is required.



 


PHYSICAL DEMANDS:


The employee may frequently 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 regularly lift and or move up to 50 lbs., occasionally lift or move 50 pounds.


 


WORK ENVIRONMENT:


 



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

  • Infrequent international travel



 


 


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 to 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: 2021-10-21 Expires: 2021-11-20

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Sr. Quality Engineer

Handicare USA, Inc.
St Louis, MO 63103

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