Job Information
Actalent Process Quality Engineer I in Plano, Texas
Description:
THE CANDIDATE WILL BE RESPONSIBLE FOR PROVIDING SKILLED TECHNICAL SUPPORT AS A QUALITY INTEGRATOR FOR THE TRANSITION FROM DESIGN TO MANUFACTURING AND QUALITY INSPECTION OF MEDICAL DEVICES. THIS INCLUDES LEADING QUALITY EFFORTS OVER DESIGN & DEVELOPMENT, SUPPLIER QUALITY,PROCESS READINESS, EQUIPMENT QUALIFICATION, AND FACILITIES SETUP TO IMPROVE PRODUCT QUALITY AND CAPACITY.
ROLE AND RESPONSIBILITIES
SUPPORT CHANGE CONTROL EFFORTS ASSOCIATED WITH THE TRANSFER FROM DESIGN TO THE
MANUFACTURING FLOOR FOR DEVICE HARDWARE AND SOFTWARE. SERVE AS PROCESS INTEGRATOR
BETWEEN THE CHANGE PROCESS AND PRODUCTION.
2+ Years' experience working with Medical Devices
INTERPRET PRODUCT AND COMPONENT SPECIFICATIONS TO SUPPORT THE CREATION AND UPDATE OF
DEVICE MASTER RECORD (DMR) AND DEVICE HISTORY RECORD (DHR) DOCUMENTS. DEVELOP AND
MAINTAIN MANUFACTURING AND QUALITY DOCUMENTATION, SUCH AS WORK INSTRUCTIONS AND
STANDARD OPERATING PROCEDURES.
IDENTIFY DOCUMENT REQUIREMENTS, COLLECT INPUTS FROM CROSS-FUNCTIONAL TECHNICAL STAFF AND
DISTILL THIS TECHNICAL INFORMATION INTO DETAILED, ACCURATE CONTENT FOR ASSEMBLY AND TESTING
DOCUMENTS FOR NONTECHNICAL AND TECHNICAL USERS.
ENSURE COMPLIANCE WITH ALL APPLICABLE REGULATIONS AND STANDARDS, INCLUDING FDA AND ISO
REQUIREMENTS.
MAINTAIN ACCURATE AND ORGANIZED RECORDS OF PRODUCTION PROCESSES AND PROCEDURES. REVIEW
ASSEMBLY PROCESSES FOR DEFINITION AND IMPLEMENTATION OF MANUFACTURING TOOLING AND
FIXTURES.
LEAD ROOT CAUSE ANALYSIS EFFORTS FOR EVENTS SUCH AS CUSTOMER COMPLAINTS, PROCESS
DISCREPANCIES AND SUPPLIER ISSUES. ANALYZES YIELD AND STATISTICAL PROCESS CONTROL DATA AND
PROPOSES CORRECTIVE ACTION EFFORTS FOR ISSUES THAT NEGATIVELY IMPACT THE PERFORMANCE OF THE
MANUFACTURING OPERATION.
APPLIES COMMON ENGINEERING PRINCIPLES TO IDENTIFY AND QUANTIFY IMPROVEMENT OPPORTUNITIES
FOR PRODUCT AND PROCESS METHODOLOGY AND WILL CONSIDER ALL ASPECTS OF THE MANUFACTURING
PROCESS INCLUDING MANPOWER, METHODS, MATERIALS, MACHINES, MEASUREMENTS, AND THE WORK
ENVIRONMENT.
COLLABORATE WITH CROSS-FUNCTIONAL TEAMS TO IDENTIFY AND IMPLEMENT PROCESS IMPROVEMENTS.
TROUBLESHOOTS EXISTING PROCESSES AND TECHNOLOGIES.
PROVIDE DIRECT ASSISTANCE TO THE PRODUCTION FLOOR FOR ASSEMBLY / PROCESS / TECHNICAL ISSUES
AND WORK TO ENHANCE AND SIMPLIFY DOCUMENTATION UTILIZED BY PRODUCTION FLOOR ASSOCIATES IN
CONJUNCTION WITH THE TECHNICAL FUNCTIONS.
REVIEW AND APPROVE BOMS, DRAWINGS/LABELING (NEW/MODIFIED), SPECIFICATIONS.
DEVELOP VALIDATION PLANS AND PROTOCOLS AND DRAFT FINAL REPORTS.
ANALYZE TEST DATA USING STATISTICAL METHODS
Additional Skills & Qualifications:
QUALIFICATIONS AND EDUCATION REQUIREMENTS
BACHELOR OF SCIENCE DEGREE IN ENGINEERING OR OTHER SCIENTIFIC DISCIPLINE.
MINIMUM OF 1-2 YEARS OF RELEVANT EXPERIENCE IN A MANUFACTURING OR QUALITY ENGINEERING
ENVIRONMENT, OR ADVANCED DEGREE WITH 0 YEARS OF EXPERIENCE.
COMMUNICATION SKILLS TO CONVEY TECHNICAL MATTERS WITHIN THE ENGINEERING TEAM, WITH
SUPPLIERS, MANUFACTURING, AND THIRD PARTY TEST LABORATORIES
PREFERRED SKILLS
UNDERSTANDING OF COMPLEX, ELECTRO-MECHANICAL, SOFTWARE-CONTROLLED DEVICES
GOOD FOUNDATION IN QUALITY AND COMPLIANCE
STRONG UNDERSTANDING OF STATISTICAL ANALYSIS TOOLS.
FAMILIAR WITH US FDA GMP, ISO STANDARDS, AS WELL AS COMPARABLE INTERNATIONAL REGULATORY
AGENCY REQUIREMENTS FOR PROCESS AND QUALITY CONTROL IN MEDICAL DEVICE OPERATIONS.
FAMILIARITY AND UNDERSTANDING OF TECHNICAL DISCIPLINES RELATED TO QUALITY CONTROL, QUALITY
ASSURANCE AND VALIDATION.
ABILITY TO WRITE AND UNDERSTAND TECHNICAL DOCUMENTS AND PROCEDURES.
Experience Level:
Intermediate Level
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
Actalent
- Actalent Jobs