Documentation Analyst I (Aesthetics Med Device) (Bothell WA)

Principal Responsibilities and Duties

• Note: The following are meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title.
• Administer the Agile Change Order, Manufacturing Change Order, and Deviation processes, including initiation, checking, routing, releasing, implementing, and final review
• Cook with other disciplines to ensure change orders are complete and meet documentation requirements prior to routing
• Cook with other disciplines to ensure change order implementation actions are complete; monitor and report on action status
• Lead change review meetings
• Aid other disciplines with Agile tasks
• Maintain physical document control records (e.g., DHRs), including performing reviews, sorting, filing, packing, and assisting others in retrieval
• Aid in administrative Agile tasks such as user management, generation of monthly metrics, and supporting quality audits
• Aid in ensuring that documentation complies with GMP and regulatory requirements
• Aid in development of new and revision of existing Agile processes

Experience, Education, Training, Skills, Traits

• Proficient in the use of PC software (MS Word, Excel, etc.)
• Effective verbal and written communication and interpersonal skills.
• A self-motivated, self-directed and detail-oriented individual, able to work in a team and small company environment with minimal supervision.
• Must have excellent work ethic, personal responsibility, initiative, and teamwork skills.
• Familiarity with FDA QSR and ISO 13485 principles, especially those regarding documentation, change control, and configuration management, a plus
• Experience with Agile or other PLM systems a plus
• Experience working in a regulated environment a plus

Language And Verbal Skills

• Ability to read, analyze, and interpret governmental regulations, general business periodicals, professional journals, and technical procedures.
• Ability to write procedures, reports, and business correspondence in English.
• Ability to effectively present information and respond to questions from groups of managers, and internal customers.
• Ability to clearly and concisely convey project accomplishments, obstacles, issues, and project status.

Math Skills

• Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

Analytical And Reading Skills

• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to read regulatory, technical and clinical literature and documents and extract important concepts.

Physical Requirements

• May be required to perform lifting tasks of up to 20 pounds for short durations.
• Duties of this job may involve sitting for extended periods of time.
• Duties also involve daily keyboard data entry.

Specific vision abilities required by this job

• Close vision.

Work Environment

• Most work will be performed in an office environment.
• The noise level in the work environment is usually low to moderate.

Safety

• Solta Medical is committed to the health and safety of our employees.
• We expect that all employees will perform their responsibilities while maintaining a safe, cooperative, and productive work environment, thus ensuring the health and safety of themselves and others.

Pay

The range of starting base pay for this role is $25-34 per hour. Actual starting pay will be based on a wide range of factors including, but not limited to, relevant skills, experience, qualifications and location.

Benefits

• Comprehensive Medical (includes Prescription Drug), Dental, Vision, Flexible Spending Accounts
• 401(k) with matching company contribution
• 3-weeks paid time off plus paid sick time
• Stock purchase plan
• Tuition reimbursement
• Parenthood leave
• Short- and long-term disability
• Life insurance
• Accidental death & dismemberment insurance
• 12 paid holidays (including floating holidays)
• Employee referral bonuses
• Employee discounts

EEO Statement

We are an Equal Opportunity Employer. EOE Disability/Veteran. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration.