Associate, Operations Quality
hace 2 semanas
- Handle the quality incidents in production through manufacturing systems.(Rework/EC(Engineering Change)/RMA((Returned Material Authorization)/)/OBA(Out of Box Audit) /Training)
- Supports audits to help maintain compliance, particularly for the validation on corrective actions (system/process/product)
- Monitor quality KPIs and in process issues
- RFPY(Rolled First Pass Yield)/OBA(Out of Box Audit)
- RMA (Returned Material Authorization)/DPQL(Delivered Product Quality Level)
- Customer feedback
- LRR(Line Reject Rate)/ RI Flag(Receiving Inspection Flag)/WWQA(World Wide Quality Alert)
- Assist to document the quality instructions and quality reports based on customer/product/material requirement
- Provide production line workflow support (Shop Floor Control System routine activities, Purge process, Trial run,etc.)
- Perform the first article inspection for supplier and customer parts & products and all changes
- Develop sterilization procedures as required based on corporate and local procedures, best industry manufacturing
- Plan, develop and execute sterilization validations, revalidations and product adoptions.
- Support routine sterilization activities
- Coordinates microbiology laboratory assays and methods setup (test method validation) with Microbiology Lab
- Get in contact with the sterilization facility, get quotes and scope of validation work.
- Generates and reports trend analyses for sterilization processes.
- Supports execution and maintenance of sterilization revalidation program including the coordination with the applicable
- Assists Environmental and Product Monitoring testing tasks as applicable, including the review/verification of their
- Develops specifications, standard operating procedures, work instructions, test procedures, and verification/qualification
- Resolve Sterilization excursions (NCRs, SCARS, CAPAs) related with sterilization.
Knowledge/Skills/Competencies:
- Knowledge of quality metrics ,ISO 13485, 21 CFR and IPC standards and processes
- Knowledge of manufacturing processes
- Basic quality tools (7 tools, SPC, etc) Good analytical and problem solving skills.
- Ability to effectively communicate with a wide variety of internal and external customers.
- Good team work
- Microbiology, Chemestry and Biology fundamentals
Physical Demands:
- Repetitive manual movements (e.g., keyboarding)
- Sustained visual concentration on small areas, such as monitors, screens
- The job works in a normal office environment with no undue exposure to noise, odours, dust, drafts, etc
Typical Experience:
- 1 to 2 years
Typical Education:
- Bachelor's degree
Notes:
Celestica is an equal opportunity employer.
All qualified applicants will receive consideration for employment and will not be discriminated against on any protected status (including race, religion, national origin, gender, sexual orientation, age, marital status, veteran or disability status or other characteristics protected by law).
COMPANY OVERVIEW:
Celestica (NYSE,
TSX:
CLS) enables the world's best brands.
Through our recognized customer-centric approach, we partner with leading companies in Aerospace and Defense, Communications, Enterprise, HealthTech, Industrial, Capital Equipment and Energy to deliver solutions for their most complex challenges.
As a leader in design, manufacturing, hardware platform and supply chain solutions, Celestica brings global expertise and insight at every stage of product development - from drawing board to full-scale production and after-market services for products from advanced medical devices, to highly engineered aviation systems, to next-generation hardware platform solutions for the Cloud.
Headquartered in Toronto, with talented teams spanning 40+ locations in 13 countries across the Americas, Europe and Asia, we imagine, develop and deliver a better future with our customers.
Celestica would like to thank all applicants, however, only qualified applicants will be contacted.Celestica does not accept unsolicited resumes from recruitment agencies or fee based recruitment services.
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