Quality Engineer II
Posted on: November 11, 2019
Overall Purpose: This position aligns with Diality's existing
organizational chart growth plan. The intent of this position is to
support key activities within the Quality function focused on the
- Product inspection and associated infrastructure (Receiving,
- Supplier management
- Quality Systems support (processes, auditing, QMS + PLM
- Project-specific Quality responsibilities during Design
V&V, Design Transfer, and Post-production Duties &
- Support implementation, maintenance, and improvement of Quality
System processes and procedures.
- Support Design Control activities for existing medical device
- Provides input regarding appropriate statistical methods and
- Coordinate investigation of product failures from complaints,
CAPAs, Design Verification/Validation deviations, NCMRs, and other
- Support all sustaining quality activities related to Receiving
Inspection, In-process Inspection, Supplier Management, Contract
Manufacturing, and field non-conformances.
- Manage Supplier Corrective Action Requests (SCARs) by leading
and participating in teams to investigate, analyze, correct and
drive corrective action for supplier related nonconformances.
Communicate effectively with suppliers regarding SCARs and other
quality issues. Evaluate impact of supplier change requests; lead
cross-functional teams to identify and execute appropriate actions.
- Demonstrated experience as a Quality Engineer or equivalent
role within a regulated industry (medical device preferred).
- Demonstrated knowledge of medical device manufacturing
processes (GMP), Product inspections, non-conforming material
resolution, CAPA, and record keeping.
- Demonstrated experience with internal and supplier auditing,
process validation, metrology, and inspection equipment.
- Bachelor's in Engineering or Scientific field with a minimum 5
years of experience required.
- Medical device experience; or experience in a regulated
- Strong proficiency using MS Office Suite (e.g., Word, Excel,
PowerPoint, and Visio) Knowledge & Abilities:
- Strong understanding of and ability to interpret and apply ISO
13485, ISO 14971, and 21 CFR Part 820 regulatory standards.
- Strong knowledge and understanding of principles, theories, and
concepts relevant to Quality Engineering, including statistical
- Flexibility and strong organizational skills with ability to
prioritize multiple tasks.
- Ability to work as a collaborative team member as well as
- Prior experience with electronic QMS, PLM, ERP systems
preferred. Working Environment: This position primarily works in an
office environment. It requires frequent sitting, standing and
walking. Daily use of a computer and other computing and digital
devices is required. May stand for extended periods when
facilitating meetings or walking in the facilities. Travel: Ability
to occasionally travel domestically.
Keywords: Diality, Irvine , Quality Engineer II, Engineering , Irvine, California
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