Overview: 

The purpose of this position is to assist Quality Assurance Management in maintaining a
department of qualified, motivated, and respected Quality Engineers. This includes assisting
all 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
Engineering, Operations, Sterilization and outside suppliers.

 

Responsibilities: 

. Represents the Corporation, Division and Quality Department in a professional manner.

. 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.

. Creates, reviews and approves Quality System Documents . Creates, reviews and approves
Product Documents . Creates, reviews, and approves Protocols, Process and Product Validations,
Stability Protocols . Mentors entry point staff . Provides supervision to technicians and
engineers . Assists in the review and interviews of potential candidates. 

. Creates, reviews and approves documents required for Design History File.

. Creates, reviews and approves Risk Assessments such as FMEA, FMECA or FTA.

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

. Performs Internal or Supplier Quality System Audits.

. Ensures compliance to Department and Division procedures.

. 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 required.

. Tracks and trends of Quality Indicators. 

. Interfaces with manufacturing facility or other Division Facilities.

. Serves as Independent QA Reviewer and Chairperson for Design Reviews.

 

Qualifications: 

. Ability to perform engineering work of a broad nature with little or no

direction from Quality Management. Generally, receives guidance on novel or

controversial problems.

. Extensive knowledge of medical device regulation, industry or

international standard, including management responsibility. Ability to

understand Division and Plant Quality Systems and be able to implement

systemic changes to enhance product quality and improve business efficiency.

Ability to interface with regulatory bodies to present technical

information.

. Comprehensive knowledge of quality systems and relationship to business.

. Has experience in writing protocols/validations and has fundamental

knowledge of validation principles.

. Understands basic applied statistics, statistical sampling plans, and

statistical process control and advanced statistical methodologies such as

DOE and Taguchi.

. Ability to serve in leadership roles on projects or assignments.

. Comprehensive understanding of auditing principles and ability to perform

as a lead auditor.

. Ability to participate and provide leadership on teams and maintain

positive work environment with those teams. Understands team functions,

leadership techniques and project management methodologies. 

. Broad knowledge of manufacturing processes. 

. Excellent communication skills (verbal, written, and presentation).

Understands how to present information dependent upon the level of the

audience. 

. Understands Fundamentals of Engineering Principles.

. Ability to effectively manage time.

. Ability to handle multiple task assignments.

. Ability to translate quality requirements into product specifications.

. Ability to interpret Regulations, Corporate, Division and Department

Procedures.

. B.S. in Engineering, Engineering Technology, Science a minimum. 

. American Society of Quality (ASQ) certification (CQE, CQA, CQM, etc.)

. Minimum 4 years of experience with FDA regulated industry including three

years on product development programs.

 
 
 
 
 
 

 
Contact: 
 
 
Company: Alpha Scientific, Inc. 
Email: [email protected]