Technical Writer - I
Pine Point, ME 04074, USA
- Working under general supervision, will revise technical documents and procedures to drive production changes and process improvements.
- Works with cross-functional teams to achieve alignment on documentation deliverables. Delivers high-quality documentation that is compliant with the Quality System.
- Writes/revises Document Control Departmental Work Instructions (DWI’s) and/or Standard Operating Procedures (SOPs).
- Maintains a safe working environment.
- Designs forms and new formats which are used as templates for controlled and development documentation.
- Become efficient with use of Agile and the company Scarborough QMS. Become efficient with Maximo CMMS
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Convert relevant product data and information into a form that meets Quality and submission requirements.
- Assist engineers and designers in managing technical files throughout the CO process. Make day-to-day document control and change control decisions following established procedures and guidelines without prior review with immediate manager.
- The output provided by the incumbent/candidate is subject to external audit (e.g. FDA, ISO). The lack of accuracy and timeliness will impact the Quality system at site and division levels.
- Associates Degree (± 13 years) In Business Administration or related field an equivalent combination of education and work experience
- Bachelors Degree (± 16 years)
- In related field preferred