37 applicants
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Actalent ยท 1 week ago
Process Quality Engineer I
Plano, TX
Full-time
Hybrid
Entry, Mid Level
1+ years exp
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Responsibilities
Provide skilled technical support as a quality integrator for the transition from design to manufacturing and quality inspection of medical devices.
Lead quality efforts over design & development, supplier quality, process readiness, equipment qualification, and facilities setup to improve product quality and capacity.
Support change control efforts associated with the transfer from design to the manufacturing floor for device hardware and software.
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 technical information into detailed content for assembly and testing documents.
Ensure compliance with all applicable regulations and standards, including FDA and ISO requirements.
Maintain accurate and organized records of production processes and procedures.
Lead root cause analysis efforts for events such as customer complaints, process discrepancies, and supplier issues.
Apply common engineering principles to identify and quantify improvement opportunities for product and process methodology.
Collaborate with cross-functional teams to identify and implement process improvements.
Troubleshoot existing processes and technologies.
Provide direct assistance to the production floor for assembly/process/technical issues and enhance documentation utilized by production floor associates.
Review and approve BOMs, drawings/labeling (new/modified), specifications.
Develop validation plans and protocols and draft final reports.
Analyze test data using statistical methods.
Qualification
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Required
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
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.
Company
Actalent
Actalent is an engineering and sciences service company.
5,001-10,000 employees
H1B Sponsorship
Actalent has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (31)
2022 (63)
2021 (20)
Funding
Current Stage
Late StageLeadership Team
Scott Anderson
Chief Financial Officer
Alison Deming Bucek, SPHR, SHRM-SCP
Human Resource Business Partner
Recent News
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