Overview
Laboratory Assistant – NY Jobs in New York, NY at Kindbody
The Quality Engineering Manager will lead all Quality Engineering activities and incoming quality issues. Ensure all quality related systems of the plant are established and documented to provide a safe and effective product. Build sound technical and organizational competence within area of responsibility. Ensure the systems and products comply with applicable government regulations. Comply with all embecta quality policies, procedures, and practices through consistent application of sound quality engineering/assurance principles.
Essential functions include but are not limited to:
Evaluate, design, implement and improve a production and process control strategy to achieve quality management and plant objectives.
Participate on material review board. Provide quality engineering support to product/process validation effort.
Review and approve changes to the device master record. • Review and approve qualifications and validation protocols and results.
Develop and approve strategic quality planning.
Provide appropriate oversight and direction to quality engineering projects. Support continuous improvement processes, i.e.: lean manufacturing, root cause determination, control plans and six sigma and statistical problem solving.
Oversee the vendor qualification and certification programs in collaboration with supply management and supply quality engineer.
Comply with all embecta quality policies, procedures, and practices through consistent application of sound quality assurance principles.
Comply with all local, state, federal and embecta safety regulations, policies, and procedures.
Provide effective quality engineering leadership in teamwork development, effective communication, and quick responses to customer needs
Build organization capability for quality engineering in the selection and mentoring of professionals.
Build a strong interactive, working, and strategic relationship with embecta Holdrege manufacturing and Global quality management and other staff.
Function as primary engineering respondent during FDA, ISO and other 3rd party audits and follow up on any action plans.
Performs other duties as assigned by the manager and required to support the needs of the business
Basic Requirements:
Bachelor’s degree in engineering, Quality Assurance, Mathematics/Statistical or Science related field required
3+ years in Medical Device Manufacturing, Validation, PFMEA
1+ years management experience
Quality tools (MSA, TMV, Capability Analysis, PFMEA, Validation, 8D, 5Y)
Quality Systems
strong knowledge of statistical and sampling plans
Preferred Requirements:
Master’s degree desirable
Project Management
Six Sigma desirable
Risk Management experience
Strong applicable knowledge on Statistical and Sampling Plans
Root Cause analysis principles
CAPA
Onsite interview REQUIRED.
Fulltime Benefits: Relocation assistance, not a set in stone number, will not sell houses and provide assistance for a family of 4.
Full medical, dental, 401k match benefits.
No option for contract at this time. Only FTE!
Contact:
Mani – Team Lead HR Recruiter
Email: [email protected]
Cell: (925) 241-5753 Ext 106
Info Way Solutions LLC
“Email is the best way to reach me”
Job Type: Full-time
Pay: $130,982.00 – $131,180.00 per year
Benefits:
401(k)
401(k) matching
Dental insurance
Health insurance
Life insurance
Paid time off
Vision insurance
Schedule:
8 hour shift
Day shift
Monday to Friday
Education:
Bachelor’s (Preferred)
Experience:
Medical Device Manufacturing: 4 years (Required)
Management: 1 year (Required)
Validation: 3 years (Required)
Quality Assurance: 3 years (Required)
Quality (MSA, TMV, Capability Analysis, PFMEA, Validation): 3 years (Preferred)
Quality systems: 2 years (Preferred)
Risk management: 3 years (Preferred)
Six Sigma: 3 years (Preferred)
Root cause analysis: 3 years (Preferred)
CAPA: 1 year (Preferred)
Ability to Commute:
Holdrege, NE 68949 (Preferred)
Ability to Relocate:
Holdrege, NE 68949: Relocate before starting work (Preferred)
Work Location: In person
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Title: Laboratory Assistant – NY
Company: Kindbody
Location: New York, NY
