Sr. Quality Engineer
The purpose of this position is to manage the design quality aspects of the assigned 
product lines. This includes assisting other Quality Engineers with the proper tools and 
guidance to be successful in performing their work, as well as providing them with a work 
environment conducive to personal and professional success.  Additionally, the Senior 
Quality Engineer functions as a subject-matter resource for interfacing with cross 
functional partners in Engineering, Operations, Sterilization, and outside suppliers

DUTIES AND RESPONSIBILITIES:

Participates on Project Team as Quality Representative.  Ensures that principals of Design 
Control are applied to Product and Process Changes and New Product Development.

Provides Quality Assurance leadership for Project Teams or Quality Department.

Builds, reviews and approves Quality System Documents (CAPA, Audits)

Crafts, reviews and approves Product Documents, such as Design History Files

Creates, reviews, and approves Protocols, Process and Product Validations, Stability 
Creates, reviews and approves Risk Assessments such as FMEA, FMECA or FTA.

Protocols, Software Validation documents

Mentors staff

Provides supervision to technicians and engineers

Analyzes process and product non-conformances and implement comprehensive corrective and 
preventive action plans.

Performs Internal or Supplier Quality System Audits.

Participates and has membership in trade and/or professional organizations to ensure that 
state-of-the-art industry standards are communicated into the division in an efficient, 
timely, and accurate manner.

Performs Complaint review and investigation as the need arises.

Tracks and trends Quality Indicators.

Collaborate with manufacturing facility or other Division Facilities.

Serves as Independent QA Reviewer and Chairperson for Design Reviews.

Key Skills and Experience:

Ability to work independently

Regulatory knowledge and experience including but not limited to FDA, MDSAP, PMDA, CFDA

Demonstrated experience working with international suppliers/manufacturers as it relates 
to product quality and reliability

Demonstrated history of successfully interpreting regulations, and procedures

Demonstrated skill in statistical analysis and applied statistical methodologies

Knowledge and understanding of IEC 60601 standards

Basic Requirements:

Minimum 4 year Degree required; but not specific to a field

BS Degree in Engineering, Science or Technical Field; preferred but not required

Capital system experience (Electro-mechanical) preferred

5 years of experience in FDA regulated environment, with 3 years of product design 
experience preferred

2 years of Quality Engineering experience in a regulated environment

ASQ Certification preferred