**Summary Description:** - The position is to support the European Union Medical Device Regulation (EU MDR) program at Añasco, PR. -The incumbent will be supporting the following activities to ensure conformance with EU MDR for technical filing of products manufactured at the company, included in the EU MDR program. • Data Gathering - Participate in the discovery and compilation of required documentation to be evaluated. • Gap Assessments - Assess of all manufacturing documentation such as product device master record (drawings, specifications, bill of materials, production router/instructions, procedures, labeling), process flow charts, incoming inspections, in-process inspections, final inspections, validation plans and process validations, among others. • Remediation Plan - Perform tasks identified as part of the remediation plan including, but not limited to: validation documentation generation and execution (change control, validation plans, validation protocols, validation closure reports, technical reports / memos) and manufacturing documentation update through site change orders system. The incumbent will be working with cross functional areas on activities described above. Responsible for the delivery of tasks to ensure conformance to the project plan schedule. Knowledge, skills, and abilities: • Must have knowledge of European Union Medical Device Regulation (EU MDR 2017/745), European Union Medical Device Directive 2007/47/EC and ISO13485:2016 Medical Devices - Quality Management Systems • Knowledge of FDA, OSHA, EPA, and GMP's and ISO requirements. • Proficiency in usage of Minitab and equivalent tools to perform advanced statistical analysis. • Able to develop technical documentation such as: Change Controls, Validation Plans, Validation Protocols, Technical / investigation reports, SOP, and others. • Must have excellent communication skills and a strong track record of working cross-functionally. • Ability to assess technical issues and develop solutions utilizing an analytical approach to problem solving. • Teamwork oriented and self-starter. • Fully bilingual (English and Spanish). • Availability to work extended hours in a day and weekends as required. **Education and/or experience:** • BS in Science or Engineering, preferably Mechanical, Industrial, Electrical, Chemical, or Biomedical. • Hands-on experience with EU MDR or MDD remediation projects, compliance projects and process validation required. • Experience with managing documents within electronic PLM system. • Experience with working with cross functional team. • Minimum of 5 - 7 years of experience in the medical device and/or pharmaceutical manufacturing environment; with at least five (5) years in manufacturing process, quality or validation engineering position and preferably with exposure to Packaging Validations, Design Control and Product/Process Transfer. **Pay Details:** $28.39 to $47.32 per hour Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Equal Opportunity Employer/Veterans/Disabled To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.adecco.com/en-us/candidate-privacy The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable: + The California Fair Chance Act + Los Angeles City Fair Chance Ordinance + Los Angeles County Fair Chance Ordinance for Employers + San Francisco Fair Chance Ordinance