JOB DESCRIPTION

Partial Job Description

1) Develop, implement and manage systems and methods for identifying, monitoring and preventing internal and external product failures and their associated costs

2) Provide a variety of quality engineering services to all other company functions which ensure compliance with regulatory agencies

3) Manage and direct QE team

4) Develop, implement and manage systems for monitoring product performance

5) Identify and report performance trends using sound statistical methods with leadership, integrity and vision

6) Develop, implement and manage QE supported CAPA programs to ensure product quality

7) Develop test methods and perform failure investigations in order to determine the root cause of failures on assigned projects

8) Coordinate corrective action efforts with other groups (such as Manufacturing and Engineering) to ensure teamwork and integrated efforts to achieve objectives

9) Participate in product development functions by recommending and implementing quality engineering plans and documentation that ensure quality objectives are achieved

10) Determine and recommend sampling plan, equipment requirements, measurement techniques and training requirements that will assure specific quality levels

11) Develop strategies and programs that qualify and ensure external vendors supply products that conform to company specifications and quality requirements

12) Review and provide recommendation on test protocols, requests for design changes and requests for product deviations to ensure documentation, methodology and overall content comply with quality objectives and policies

13) Ensure integrity of environmental monitoring, controls and release of product (microbiology)

14) Take responsibility for direction of QE support in Design Control/New Product Development teams

15) Take responsibility for validation master plan and validation protocols to support manufacturing and business quality requirements

16) Ensure that there are embedded Quality Engineers in both medical device consumables and capital systems environments

17) Take responsibility for technical test and analysis functions, including FTIR and SEM

18) Provide leadership to supplier quality processes

19) Ensure unfailing commitment to the safety of company customers and patients

20) Manage day-to-day and project work of QA engineers, technicians and inspectors

21) Develop strategic direction for the department with VP

22) Direct functional departments and key areas of task, including Microbiology, QE Validation, new-facility qualification, QE (laser), QE (catheter), QE Test and Analysis, Supplier Engineering and Supplier Quality and QE Design Control

CRITICAL REQUIREMENTS

• Qualifications / Skills Required

  
  

  1) Masters degree in Engineering or relevant technical field

  
  

  2) BS in an Engineering discipline

  
  

  3) CQE Certification  ASQ (preferred)

  
  

  4) Minimum 10+ years of Quality Engineering or Product development experience in medical device industry

  
  

  5) Minimum 4+ years of leadership/management experience in Quality Engineering

  
  

  6) Knowledge of complex modeling

  
  

  7) Proficient with CAD tools (strongly preferred)

  
  

  8) Understanding of domestic and international design control

COMPANY INFORMATION

Sterling-Hoffman is a retained executive search firm that specializes in representing life sciences and technology companies in matters of high impact talent acquisition. Our clients include market leaders and venture capital-backed startups in industries such as: medical device, biotechnology, pharmaceuticals, enterprise software, clinical research, and laboratory services. You may view more of our jobs here: http://www.sterlinglifesciences.com Your privacy is important to us: we will never share your resume without your permission. Please note that only qualified applicants will receive a response. We encourage you to apply for as many jobs as you believe you are a fit for, but strongly suggest that you include your salary information as job seekers who provide salary information are likely to be reviewed sooner. ===================== TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Biotechnology Recruiter, Pharmaceutical Recruiter, Medical Device Recruiter, Biotechnology Career, Clinical Research Job, Regulatory Affairs Job, R&D / Scientist Job, Product Manager Job, Medical Device Sales Job, Biotechnology Sales Job, Quality Assurance Job, Engineering Job, Laboratory Jobs, Microbiology Jobs, CEO Jobs, Marketing Jobs, Manufacturing Jobs, Oncology Jobs, Cardiology Jobs, Hematology Jobs, Medical Jobs

JOB INFORMATION