Merocel is a product line that is part of the ENT product portfolio. Located in Mystic, CT, the facility manufacturers nasal dressings, epistaxis packing, sinus packing, ear packing and ear wicks for epistaxis, post-operative surgery and trauma.
- Prepares, cleans, disinfects, and/or sterilizes instruments, materials, products, and/or supplies.
- May also be involved in establishing requirements for the transfer of methodology from R&D.
- Develops, validates, and implements controlled environment methods.
- Applies existing techniques and procedures with recommendations and implementation of modification for improved efficiency, or devises and develops new analytical methods and techniques.
- Follows protocols and regulations in order to clean, store, and/or deliver products, supplies, and/or instruments.
- Interprets and evaluates the analyses in terms of accuracy and precision compared against established specifications and recommends and implements corrective action where necessary.
- Performs qualitative tests or quantitative assays on samples using techniques that vary from use of standard analytical equipment to highly modern and automated instrumentation.
- Analyzes chemical, biological or microbiological products, raw materials, in-process materials, release test samples or stability samples in support of the company’s quality program.
- Manages external standards pertaining to sterilization and microbiology for medical devices
Familiar with ISO and guidance documents related to sterility assurance – sterilization (ISO 11137, ISO TIR 13004, AAMI TIR 39), microbiology (ISO 11737 series), cleanrooms (ISO 14644 series, ISO 14698, AAMI TIR 52), and quality systems (ISO 13485)
- Act as a SME on sterility assurance and as a point-of-contact for regulatory audits.
- Reviews sterilization deviations and provides technical support to assist with the release of sterilization loads and ensure compliance to procedures and regulatory requirements and ensure product quality issues are addressed
- Develops technical solutions to a wide range of difficult problems. Solutions are innovative and consistent with the organizations objectives and quality system requirements.
- Demonstrates understanding of the audit process including types of audits, planning, preparation, execution, reporting results, and follow-up.
Qualification & Experience:
- Bachelor’s Degree in Science or technical field with 4 years of work experience in microbiology, sterilization, and/or biocompatibility experience OR Advanced Degree in Science or technical field with 2years of work experience in microbiology, sterilization, and/or biocompatibility experience.
- Hands on experience and deep knowledge of radiation sterilization (dose mapping, dose setting, dose audits, routine processing, sterilization validation, bioburden validation, microbial characterizations, VDmax methodology, and Method 1 methodology).
Vacancy Type: Full Time
Job Functions: Research
Job Location: New Haven, CT, US
Application Deadline: N/A