Location: Daytona Beach
Posted on: November 6, 2019
Medical device company focused on disposable medical device
contract manufacturing near the Daytona Beach area.
*must be a US citizen or permanent resident*must have a medical
device engineering background
JOB TITLE: Regulatory Compliance/Sterilization Engineer(50%
Regulatory Compliance and 50% Sterilization Engineering)
REPORTS TO: President & C.O.O.CLASSIFICATION: ExemptSTATUS:
SUMMARYResponsible for the hands-on execution associated with
projects in Medical Device manufacturing regulatory compliance,
work performed by our contract sterilizer, and related
microbiological testing, and for company compliance to ISO and FDA
- BS in Engineering; Chemical, Mechanical, Biomedical or
- 5+ years in medical device sterility assurance, sterilization
operations or testing environment.
- 5+ years in medical device Regulatory Compliance
- In-depth knowledge of industrial sterilization modalities (i.e.
Ethylene Oxide and Radiation sterilization).
- In-depth understanding of the following standards and
regulations ISO 11135, ISO 17665, ISO 11137, ISO 14644, ISO 13485,
FDA 21 CFR Part 820
- Expert knowledge of GMP compliance (FDA, BS/EN, ANVISA,
- Strongly desired but not required - Regulatory Affairs
- Previous experience with Class II, Single-Use and Class III
medical devices preferred.
- Assists new product development efforts by leading the review
and approval of sterilization validations and product adoptions.
This includes writing protocols and summary reports for both paper
and physical adoptions to meet applicable ISO and FDA
- Leads and monitors annual evaluation requirements of
sterilization processes to ensure compliance to applicable ISO and
- Ensures proper execution of sterilization validations. Works
with customer and contract sterilizer to ensure timely and accurate
execution of validations.
- Provides technical support and act as subject matter expert for
contract ethylene oxide and gamma sterilization, non-routine
testing (Bacterial endotoxin; Bioburden; Biocompatibility; EO
residual testing; Shelf life/aging; and Transportation),
maintaining flow of development and commercial products.
- Works with contract sterilizer and customers as necessary to
address any anomalies during the sterilization cycle. All anomalies
are to be resolved in 48 hours or less of identification.
- Develops and optimizes sterilization cycles with the intent of
improving cycle times, reducing lead times, and sterilization of
- Oversees and ensures compliance to standards for bioburden and
environmental monitoring programs for all products and cleanrooms.
100% compliance to standards.
- Leads environmental testing and reporting by developing and
reviewing protocols, test plans and coordinating with service
- Develops Standard Operating Procedures, Manufacturing Work
Instructions, Test Methods and provide on-site training to
applicable technical staff.
- Establishes preventive maintenance program for sterilization,
requalification, product loading, and material handling. 100%
compliance with Federal, State and local safety/environmental
- Leads or participates in auditing contract labs and
- Provides direction to company personnel to establish policies,
procedures and accountability measures that ensure regulatory
- Participates in product development through involvement in
project team meetings, including risk assessment(s)
- Reviews and approves test protocols and reports (DVT,
biocompatibility, sterilization, packaging, shelf-life, etc.) to
ensure they will meet regulatory requirements
- Assists in the development, review and approval of product
labels, instructions for use, and promotional materials to ensure
regulatory requirements are met.
- Responsible for leading and executing assigned activities
associated with regulatory compliance. Keeps abreast of changes to
regulations and ensures Quality System complies with any new
regulations. Zero (0) major ISO, FDA or customer findings because
of an audit.
- Acts as the Management Representative for all external audits
including FDA, ISO and Customers. Hosts representative and ensures
requested information is provided so that the audits can be
completed quickly and accurately. Makes sure the audit findings are
handled properly with the QMS and that any actions are completed
properly and in a timely manner. Communicates as necessary before,
during and after the audits to ensure favorable outcomes.
- Coordinates continuous education and training of all company
personnel in CGMP's, QSR's and ISO standards/guidelines. Ensures
effectiveness of the training.
- Conducts Management Review process in accordance with ISO
- Develops internal audit plan, oversee internal audits and
assure that 100% of internal audits are completed per plan in both
WORKING CONDITIONS:Varying from a good working conditions in office
environment with regular exposure to manufacturing areas to
somewhat undesirable working conditions with exposure to fumes,
noise, grease and dirt, with no element continuously present to the
extent of being disagreeable. Must be able to travel within and
outside the United States.
Keywords: SearchRSA, Daytona Beach , Sterilization/Compliance Engineer, Engineering , Daytona Beach, Florida
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