Quality System Technical Writer

Nextern is hiring for the role Quality System Technical Writer. This role comes with competitive pay and a full benefits package (details below)

The Quality System Technical Writer will be responsible for producing high-quality documentation that contributes to the overall success of Nextern’s Global Quality System (QMS). This role will work collaboratively with the global Nextern team of engineers, management and users to deploy clear and compliant Quality System processes, procedures, work instructions and training materials. The role may also provide administrative support using the Nextern document management system (e.g., Agile), such as creating and processing change orders and requests.

This role will also be responsible for establishing and maintaining the labeling processes with the support of the Identification and Traceability Process Owner and the Quality System Manager. The role will also support functional teams in deployment of the labeling process according to applicable global medical device regulatory requirements. This support may include administrative support within software systems used for Nextern labeling process (e.g., Agile, Epicor).

The role may also support Nextern teams in the creation and maintenance of deliverables produced as a result of following Quality System procedures, such as non-conformance documents, corrective and preventative maintenance (CAPA) documents, Management Review materials, audit responses, QMS software validation, or complaint documents.

DUTIES AND RESPONSIBILITIES:

• Produce high-quality Quality System documentation in collaboration with stakeholders to support company initiatives or changes to industry standards and requirements.
• Establish and maintain QMS documents in accordance with Nextern procedures, writing standards and applicable Good Documentation Practices.
• Work with stakeholders to obtain an in-depth understanding of the processes and requirements.
• Develop and maintain process flow diagrams, including current state, future state and workflow diagrams.
• Provide training and mentorship to support Quality System improvements.
• Ensure adherence to Quality System procedures on a global and customer level.
• Utilization of Project Management, Six Sigma, Lean or other disciplines to improve Quality System processes.
• Performs other related duties as assigned by management.

SUPERVISORY RESPONSIBILITIES:

• · This job has no supervisory responsibilities.

Requirements

QUALIFICATIONS:

· 6-10 years of relevant experience in the medical device industry or other equivalent regulated industry. Experience preferred with ISO 13485, Medical Devices – QMSs - Requirements for regulatory purposes, FDA Code of Federal Regulations 21 CFR 820, Quality System Requirements, and Good Manufacturing Practices (GMP).

· Ability to quickly understand stakeholder input and translate into written procedures and training materials.

· Proven experience and skills in standard computer-based software programs, such as Microsoft Office. Strongly prefer demonstrated experience with Microsoft Word, Microsoft PowerPoint, Visio or other equivalent software applications.

· Must be self-motivated with ability to handle, organize and prioritize multiple tasks and able to perform under pressure to meet deadlines.

· Ability to effectively build and maintain relationships, communicate, and interact with a variety of personalities.

· Preferred Qualifications:

o Project management experience

o Bachelors degree in English, Technical Writing, or related field in lieu of fewer years of experience

o Labeling development experience, including utilization of labeling artwork/creation software solutions (e.g. Bartender).

Benefits

Nextern offers excellent benefits to fuel you in building a fulfilling life & career:

• Employer subsidized health insurance for employees
• Employer paid dental insurance
• Employer HSA contribution
• 401k plan with a company match
• 9 paid holidays (including your birthday!) + PTO and Personal days
• Gym membership subsidy
• Employee Short Term Disability, Long Term Disability, and AD&D Life Insurance