Principal Quality Engineer

Sectors:
Aerospace, shipbuilding, other transport equipment, Automotive, Electrical, optical, Engineering
Locations:
International
Qualifications:
Not specified
Contract type:
Permanent
Hours:
Full time
Salary description:
Competitive
Sub-sectors:
All
Specialist areas:
Quality assurance (main), Audit/assessment, Consultancy, Health and safety, Operational improvement, Project management, Risk management
Posted:
17/09/2020
Start Date:
ASAP
Recruiter:
Intersect ENT, Inc.
Job Ref:
950236339

Provide high level Quality Engineering support to organization by establishing and maintaining quality assurance standards that adhere to QSR and ISO regulations. Quality Assurance oversight of various Quality functions as assigned (eg NCMR, CAPA, Equipment Control and Calibration, Manufacturing Process changes, Verification and Validation and Quality manufacturing support).

MAJOR DUTIES AND RESPONSIBILITIES:

Lead and participate in quality-related activities to support product development and production/process controls.
Participate in the development of SOPs and ensure that all company employees follow written SOPs and process specifications.
Evaluate existing Quality System processes and implement continuous improvement efforts.
Support design teams by providing primary Quality Engineering support including to the generation of Design Control deliverables (eg DHF, Risk Management, Test Methods, CMC deliverables).
Author, review, and approve protocols and reports (eg Design Validation and Verification, Biocompatibility, Aging, Stability, Analytical Method Development and Validation, Test Method Validations, preclinical studies, Process Validation - IQ/OQ, PQ, PPQ).
Implement and maintain Quality System as assigned (eg Equipment Control and Calibration, Software Validation).
Investigate, review and approve NCMRs, Rework and OOS investigations.
Identify and lead implementation of preventive and corrective actions via CAPAs, audits, NCMRs, and complaint handling systems.
Participate in inspections for FDA, FDB, Notified Body (ISO) and other regulatory agencies.
Support the generation of Regulatory submissions as assigned (IDE, PMA, IND, NDA, CE Mark, substantial change applications).
Periodically inspect facility to ensure QSR/GMP compliance.
Conduct supplier audits as assigned.
Support company goals and objectives, policies and procedures, QSR, and FDA regulations.

EDUCATION/EXPERIENCE REQUIREMENTS:

Bachelors degree in Engineering/Life Sciences.
A minimum of 10 years' medical device experience, or equivalent combination of education and experience.
Experience with quality system elements pertaining to combination device products (drug/device) and cGMP familiarity is strongly preferred.

OTHER QUALIFICATIONS:

Strong written and verbal communication skills.
Good attention to detail.

Closing Date:
15/10/2020
Contact Details:
Intersect ENT, Inc.
Contact: Click apply

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