Process Quality Engineer I

2 weeks ago

Plano, United States Actalent Full time

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.

Roles 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.

+ 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.

+ ABILITY TO UNDERSTAND AND EXECUTE CORRECTIVE/PREVENTIVE ACTIVITIES RELATED TO PRODUCT AND PROCESS CONTROL AND TO PERFORM THOROUGH INVESTIGATIONS.

+ ABILITY TO ACT EFFECTIVELY AS A MEMBER OF A TEAM TO RESOLVE PROBLEMS.

+ ABILITY TO SIMULTANEOUSLY WORK ON SEVERAL PROJECTS WITH THE FLEXIBILITY TO REPRIORITIZE IN A MINIMUM AMOUNT OF TIME.

+ EXCELLENT WRITTEN AND ORAL COMMUNICATION SKILLS, INTERPERSONAL SKILLS AND PROBLEM-SOLVING SKILLS. STRICT ATTENTION TO DETAIL REQUIRED.

+ PC SKILLS TO INCLUDE MS OFFICE SOFTWARE PACKAGES SUPPORTING WORD PROCESSING, STATISTICAL DATA ANALYSIS, AND PROJECT MANAGEMENT.

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.

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