Quality Assurance Engineer- ASPICE
- Job Title
- Quality Assurance Engineer- ASPICE
- Job ID
- Northville, MI 48167
- Other Location
SUMMARY: The person in this role will perform regular project audits, process definition, process implementation, process training, generate monthly KPIs & root cause analysis, and drive project teams to ensure quality is integrated into product development activities & APQP work products. This position will work with a global organization of cross functional employees.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
· Drive the project team during the APQP process to ensure quality is integrated into all product development work products.
· Perform Product Development project audits across engineering project teams.
· Execute quality assurance tasks within the Electronics Product Development.
- Track and capture non-conformances to PD Process Audit and facilitate closure of open items through audit and open item reports.
- Reports observations/problems clearly and concisely, recognizing and highlighting specific deviations and presents possible solutions.
- Identify opportunities for Electronics Hardware, Software, & Systems Process Improvements (procedures, work instructions, process checklists, records, as needed).
- Maintain Process Traceability to ASPICE practices & ISO 26262 Tool Architecture Map.
- Analysis of KPI’s and assist in establishing effective process management using appropriate KPI’s. Communicate project related quality issues, metrics and KPI’s.
EDUCATION and/or EXPERIENCE:
Bachelor or Master’s Degree in Quality Assurance, Software Engineering, Electrical Engineering, Electronics Engineering, Aerospace Engineering, Computer Engineering, Computer Science or other technical field.
Automotive SPICE and Black Belt Lean 6Sigma experience is a plus.
Minimum of 3 – 5 years in a quality assurance role related to electronics product development in automotive, medical, or aerospace products.
· Experience of applying APQP/ASPICE processes to model-based development including guides and checks for model-based design and autocode.
· Experience in ASPICE Capability level 2-3 or CMMI audits and process development.
· Possesses and applies a broad knowledge of principles, practices, and procedures in the field of automotive, medical device or aerospace software quality assurance to the completion of difficult assignments.
· Experience and working knowledge with common related product quality and regulatory requirements for automotive, medical device or aerospace engineering:
o Automotive NPQE – APQP, PPAP, FMEA, IATF16949, ISO9001, ASPICE Capability 2 -3 Audits and Process Development, ISO26262
o Medical Device NPQE - IEC TR 80002-1, DS DS/EN 61508-6, ISO13485, ISO14671, IEC60601, FDA, ISO14971, FDA 21 CFR Part 11, FDA 21 CFR 820.30 and Sub-clause 4.4 of ISO 9001, ISO 60601-3rd Edition, BS EN 60601-1-2 and FDA General Principles of Software Validation GPSV requirements ANSI AAMI IEC 62304:2006 (formerly AAMI SW68), AAMI TIR32, AAMI TIR36, AAMI SW87, AAMI TIR45
SUPERVISORY RESPONSIBILITIES: None.
QUALIFICATIONS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
· Profound knowledge in quality planning (APQP) and Quality Function Deployment in the product development phases.
· Knowledge in software development and test tools (QAC, MxvDev, ClearCase, ClearQuest, Perforce, IBM Rational JAZZ/PTC) as well as requirements analysis tools (e.g. DOORS, PTC Integrity).
Must be computer literate, with the ability to use MS Word and Excel to create reports, spreadsheets, and presentations. Must have excellent communication skills and be able to effectively work with others in a team environment. Must be able to read and interpret engineering drawings and specifications.