Position Description 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. Interprets and evaluates the analyses in terms of accuracy and precision compared against established specifications and recommends and implements corrective action where necessary. 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. Performs qualitative tests or quantitative assays on samples using techniques that vary from use of standard analytical equipment to highly modern and automated instrumentation. May also be involved in establishing requirements for the transfer of methodology from R&D. Position Responsibilities Realizes microbial identification, testing procedures, technique and methods such as: Gram staining, Spore staining, morphological and biochemical characterization, pure cultures techniques. Realizes preservation techniques, API, BBL Crystal, Vitek, etc. Conducts testing, training, ensures timely testing, documentation and communication of results. Performs testing that serve MPROC Business. Coordinates necessary laboratory support and provides quality assurance release of finished product. Performs other position related duties as assigned. Quality Responsibilities Reports any observed or informed process and/or product non-conformities to the Supervisor. Finds resolution of Quality Situations at the area of responsibility. Reports any complaint regarding a Medtronic product to the Supervisor. Complies with all the requirements in the operational procedures at the area of responsibility in order to meet the requirements of all applicable Quality System regulations (e.g.: FDA Part 820 Quality System Regulation, ISO 13485 Quality Standard, R-PAL (Japanese QSR's). EHS Responsibilities Acknowledge and maintain commitment with the EHS Policy. Participate in the development of EHS improvement projects. Participate actively in the EHS programs to achieve the objectives and targets defined for the area. Engineers in Projects: (if apply) Ensure that the EHS considerations, legal and corporate requirements and efficiency indicators are included in new project design and project evaluation in order to maximize the cost/benefit ratio and minimize the EHS impacts and risks. Ensure that EHS performance indicators are included in the selection process of contractors. Evaluate and re-evaluate periodically the EHS performance of contractors and sub-contractors. Supervise that contractors perform their job in accordance to the EHS requirements in order to reduce, minimize or prevent EHS impacts and risks. Maintain current knowledge of the potential EHS aspects and risks of new projects. Minimum Education Bachelor Degree Basic Qualifications Background Educational: Biology, Microbiology or related field Experience: o Intermediate Level: 3 Years with Diploma/ Degree or 0 Years with Advanced Diploma/ Degree Exposure to laboratory and manufacturing environment Skills Analytical Thinking Problem Solving Interpersonal Relations Quality and Results Oriented Computer Literate Fluency speaking and writing in English and Spanish Desired/ Preferred Qualifications Background Experience in medical device, pharmaceutical, or electronic industry Experience in Qualification / Validation activities. Experience ETO, Steam, Ebeam/Gamma Experience Validation sterilization, developing risk assessment related to microbiological and sterilization Experience lead projects validations for bioburden/endotoxin Experience participating in internal and external audits as sterilization Experience: prepare and develop annual report related to sterilization Skills Teamwork Communications Continues Improvement Project Management Working Conditions Mental Components: Capacity to calculate, classify, compare, coordinate, copy, edit, evaluate, interview, instruct, read, observe, organize, plan, compile, select, request and document. Physical Components: Light work requiring physical effort, in addition, requires communication skills, capability to move from one place to another, visual discrimination and tolerance to the use of personal protection equipment. Environmental Work is performed in building's interior with normal temperature, good illumination, air condition, clean environment and minimum risk SDL2017
