Product Compliance Specialist Job Description Template
Our company is looking for a Product Compliance Specialist to join our team.
Responsibilities:
- Take on DBS Initiatives in the spirit of continuous improvement;
- Conduct product safety related investigations on field reported problems or incidents;
- Create Standard Operating Procedures on an as-needed basis;
- Evaluate or direct evaluation of OEM products and test procedures/facilities/reports per global regulatory requirements;
- Lead compliance projects on an as-needed basis;
- Generate and/or review Product Compliance test and verification plans;
- Influence and guide manufacturing engineering on regulatory related topics and engineering changes;
- Ensure SCIEX’s adherence to Product Compliance based on corporate policy, international regulations and standards;
- Review, evaluate and approve Engineering Changes;
- Perform data analysis including test results and statements of conformity;
- Develop, modify, verify and validate of test methods as needed;
- Generate data and reports relating to compliance for use in reporting SCIEX status to countries and regions.
Requirements:
- Knowledge of Environmental Compliance regulations (RoHS, REACH, Prop 65, WEEE, etc.) is an asset;
- Knowledge of European and North American regulatory requirements (CE Marking, SCC, CEC, FCC, NEC, OSHA);
- Experience generating detailed engineering reports;
- Strong communication skills;
- Familiarity with ISO 9001, ISO 13485 and ISO IEC 17025 quality system elements and operation;
- Strong self-starter;
- Familiarity with analytical instruments or medical device development is an asset;
- You work well in a team environment;
- Strong project management skills to estimate, report status, and deliver individual assigned tasks;
- Bachelors or Masters Degree in Electrical/Mechanical/Mechatronics Engineering;
- Over 2 years of product safety and EMI/EMC test experience in a corporate environment with R&D, engineering and manufacturing operations;
- Strong knowledge of Microsoft Office suite;
- Knowledge of test equipment selection, functionality, operation, and calibration requirements.