Responsibility Includes the Following Tasks

Validate new equipment, products, or processes. Prepare, execute and analyze data for IQ, OQ, PQ, SQ, TVM, and FMEAs protocols and reports.
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Train operators and engineers in validation activities.
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Investigate customer, supplier, and internal non-conformance complaints. Perform root cause investigations, determine corrective action, and verify effectiveness.
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Develop/analyze statistical data and product specifications to determine manufacturing quality standards.
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Approve customer drawings for use in manufacturing.
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Create and modify current procedures and instructions.
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Prepare/present technical Information and quality metrics to team members, customers and management.
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Serve as a professional liaison with external customers.
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Maintain working knowledge of government and industry quality assurance standards.
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Develop internal audits to ensure compliance with applicable standards/regulatory requirements and organizations and ISO.

Core Competencies

Technical Learning - Picks up on technical things quickly; can learn new skills and knowledge; is good at learning new industry, company, product, or technical knowledge; does well in technical courses and seminars.
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Problem Solving- Uses rigorous logic and methods to solve difficult problems with effective solutions; probes all fruitful sources for answers; can see hidden problems; is excellent at honest analysis; looks beyond the obvious and doesn't stop at the first answers.
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Ethics and Values - Adheres to an appropriate (for the setting) and effective set of core values and beliefs during both good and bad times; acts in line with those values; rewards the right values and disapproves of others; practices what he/she preaches.
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Action Oriented - Enjoys working hard; is action oriented and full of energy for the things that he/she sees as challenging; not fearful of acting with a minimum of planning; seizes more opportunities than others.

Job Specific Knowledge, Skills and Abilities
Knowledge - NCMRs/CARs/CAPA, Customer Complaints per million, Quantity of returned product (RMAs), DPPM, DLPM.
Skills- Skills are the proficiency to perform a certain task.
Abilities- Abilities are an underlying, enduring trait useful for performing tasks (oral comprehension, understanding information and ideas).

Experience

1-2 years of experience in similar positions (Quality Engineer I). Quality leadership experience working in a manufacturing environment, ideally in a multi-national environment.
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Education

Bachelor's Degree with a scientific or engineering emphasis.
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Professional Training & Certifications

CQE/CSSBB certification desirable.

Competencies

Values: Integrity, Accountability, Inclusion, Innovation, Teamwork