Senior Quality Engineer - Product Development

SUMMARY DESCRIPTION

Provide Product Development Quality Assurance support for the following tasks and duties: 

Facilitate from a Compliance, Quality Engineering, and Development perspective the launching of new or improved products/processes. Develops and implements new and updated Quality System procedures for ISO/QSR, such as validation protocols, product stability programs, manufacturing procedures, product & material specifications, design & development documentation, SOPs, etc.

Facilitates the development, implementation, and monitoring of quality programs and policies that ensure that the development, manufacture and distribution of medical products is in compliance with corporate policies, U.S. Food and Drug Administration regulations, ISO 13485:2003, ISO 14971:2007, the Medical Device Directive, the Canadian Medical Device Regulations (CMDR), and other applicable regulatory agencies.

 

SUPERVISION RECEIVED

Under direct supervision of Director, Quality Assurance 

 

SUPERVISION EXERCISED

Supervisory responsibility for Product Development Quality Engineering Staff, and as a Project Leader

 

ESSENTIAL DUTIES AND RESPONSIBILITIESTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

 

· Provides Quality Engineering support for product development teams.

· Provides robust and effective Design Inputs through the use of VOC, Safety, Regulatory, Requirements, and all applicable points to consider during requirements definition.  

· Leads and ensures the development of comprehensive risk management plans including Design and process FMEAs, Risk management Plans and Risk Management Reports.

· Provides robust linkage between design inputs, risk level, and reliability requirements for design outputs.

· Responsible for utilizing effective Quality Engineering techniques such as risk analysis, test method development, design of experiments (DOE’s), statistical data analysis, and development of sampling plans during product development cycle to support development of robust Design Outputs.

· Develops and executes comprehensive quality strategies for design development, verification and validation.

· Works with Product Development to present effective and meaningful phased Design Reviews.  

· Supports the development of accurate and compliant Design History Files (DHF)

· Works with Product Development teams in order to ensure all aspects of Design Transfer activities are being met.

· Develops ICH complaint Product Stability Programs. 

· Ensure accurate Device Master Records are implemented.  

· Ensures that the development is in compliance with the policies and procedures as well as all applicable regulations.

· Supports corporate Regulatory Affairs by providing information for submissions and Annual Reports.

· As required, participates in FDA inspections, ISO Certification, surveillance audits, and customer audits.

 DESIRED MINIMUM QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position:

 

· Bachelors Degree in Engineering (Biomedical, mechanical, chemical, or electrical), Master’s degree preferred.

· 7 to 10 years experience in the medical device industry, with emphasis in Design Controls, Regulation 820.30.

· Demonstrates excellent organizational and communication skills and proficiency with the MS Office Suite, and statistical software.

· Must be able to work independently with minimal supervision. 

· Must exhibit good working knowledge of statistics including coming up with statistical rationales for validations.

· Able to perform and lead up risk analysis including FMEA’s.

· Able to prioritize projects and manage Quality Engineering resources to meet organizational goals and objectives.

· Able to mentor, train, and develop Junior staff.

· Able to lead projects of major complexity.  TOOLS AND EQUIPMENT USED

· Knowledge of MS Office Suite

· Must be able to work with Minitab for statistical analysis

 

  We are committed to creating an environment where all employees are valued and respected.  We offer a competitive compensation/benefits package including 401(K) savings plan with match, medical, vision, dental, life insurance, tuition reimbursement and employee stock purchase plan.

 

Please forward all resumes and salary requirements to:  integrastaffingLC@integra-ls.com .  Website: http:/www.integra-ls.com/.  Local candidates preferred.  No agencies please.  EOE, M/F, D/V.