- Responsible for supporting the quality engineering operations of sterilization, packaging, and environmental conditions program and maintaining processes and methods following the company standards.
- Reporting on the performance of the assigned quality areas.
- Responsible to maintain regulatory compliance.
- Develops quality standards and controls. Develops product and process qualifications/validation protocols/reports for new products and existing manufacturing production lines for processes related and not limited to sterilization, packaging, and environmental conditions program, etc.
- Advises company management on quality assurance requirements.
- Review non-conforming products along with product risk assessment and perform product failure investigations.
- Drives Supplier and Production Quality improvements, including efficiency and productivity improvements while maintaining compliance.
- Analyzes or organizes analysis of biological or microbiological product testing reports, raw materials, in-process materials, release test samples, or final products in support of the company's quality program.
- Interprets and evaluates the analyses of microbiological, sterilization testing results in terms of accuracy and precision compared against established specifications and recommends and implements corrective action where necessary.
- Quality control, product release authorizations, and quarantine of all suspect or discrepant products.
- Develops Quality Instructions and Quality Standards.
- Support in the development, validation, and implementation of Test Methods.
- Suggests, implements, reviews and approves engineering changes to support product life cycle.
- Provides adequate QA support to the assigned areas and responds to Internal Audits, and takes actions as appropriate based on CAPAs, Complaint investigations, Nonconforming events, etc.
- Work with existing suppliers related to sterilization, microbiological testing, etc, to develop, validate, and implement applicable methods.
- Applies existing techniques and procedures with recommendations and implementation of modification for improved efficiency, or devises and develops new analytical methods and techniques.
- The role will seek and implement opportunities for both quality and cost improvements to the current programs.
- Oversee and ensure the success of the BET monitoring program as it is implemented and modify sampling plans as sufficient data is collected to enable the company to reduce sampling costs.
- Performs qualitative tests or quantitative assays on samples using techniques that vary from the use of standard analytical equipment to highly modern and automated instrumentation.
- Responsible for, writing, reviewing, approving sterilization technical protocols and reports.
- May assist with planning, scheduling of sterilization validations, and dose audits.
- Lead the Sterility Assurance Product Evaluation program, provide guidance with testing, write technical deviation memos, provide technical input concerning the impact product changes and sterilization deviations may have on the sterility of the product.
- Supports the Corrective and Preventive Action (CAPA) System for Quality Operations-related activities.
- Applies knowledge in Quality Systems to execute overall project assignments
- May at times guide with laboratory testing as required to include bioburden, sterility testing, and bacterial endotoxin testing.
- Reviews sterilization deviations and provides technical support to assist with the release of sterilization loads and ensures compliance to procedures and regulatory requirements and ensures product quality issues are addressed.
- Must be able to solve complex problems where analysis of situations or data requires an in-depth evaluation of various factors and determine direction and adequacy of designs and test results and recommends changes. Evaluates progress and results obtained and recommend major changes to achieve overall objectives.
- Performs mathematical calculations for D-Value, dose mapping, does the setting, cycle development
Top Skills Details:
- 3+ years of experience with:
- Bachelors degree
- Medical device
- Assurance programs
- Testing for bacterial endotoxin (LAL)
- Medical device, Quality assurance, Root cause analysis, Capa, Audit, non conforming, Nonconformance reporting, iso13485, 13458, FDA, LAL, bacterial endotoxin
Nice to have:
- Experience with terminal sterilization methods, preferably Gamma and some ethylene oxide, ebeam, etc.
- Multi-task and track multiple projects at various stages.
- Implemented BET monitoring program
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Posting ID: 608474386Posted: 2021-03-06