Sr. Quality Engineer:
Responsible for quality engineering programs for contract manufactured products including sterile, non-sterile, OTC, cosmetics and medical devices.Duties to include:
Lead quality engineering group; support new product development; develop policies and manages outsource supplier's compliance program.
Monitor outsource supplier's activities including packaging, process, sterilization, etc.
Implement quality management system in compliance with FDA's GMP's, international standards and state requirements
Manages activities such as CAPA, investigation, complaints,etc. with outsourced suppliers, etc.
Manage schedule activities for quality reporting, participates in external audits
BS Engineering; Minimum 6 years engineering experience in medical device industry; experience in regulated environment; thorough knowledge of standards such as IEC60601, CFR820, ISO13485; must have thorough knowledge of statistics and familiarity with inspection/sampling plans. Sterilization experience required. Quality Engineer: · Duties to include:
Supports new product development and implementation including inspection, test and audit procedures. Monitors and identifies needed reliability testing; procurement of needed equipment, creation of process and product validation.
Maintains sterilization standards and resolves sterility issues with outsourced suppliers. 3. Implements QMS for compliance to FDA's GMP's, international standards and state requirements
Ensures that quality reporting (e.g. incoming and in-process quality trends; returns analysis, service report analysis, categorization and CAPA activity, FMEA analysis etc.) is documented and completed on schedule.
B.S. Engineering or equivalent field of study. Highly Preferable: degree in Engineering with a minor in Microbiology; Minimum four (4) years engineering experience, preferably in microbiology engineering
Must have experience working within a regulated environment (medical devices, electronic equipment, etc.).
Must have a thorough knowledge of applicable standards and regulations such as 21 CFR 211, CFR820, ISO13485.
Must have thorough knowledge of statistics and familiarity with inspection/sampling plans.
Relevant certifications preferred. Sterilization background required. Please feel free to contact me at anytime at 727 322-1320.
Regards,
Toni Baroncelli
StaffWorks, Inc.
2935 1st Avenue North, Suite 4
St. Petersburg, FL 33713
phone: (727) 322-1320 | fax: (727) 323-3512
toni@staffworks.net | www.staffworks.net