Documentation Specialist II

Starkey is hiring a Documentation Specialist II for our Global reputed company in reputed company Prairie, MN. This role is primarily remote, with occasional time required to be onsite in reputed company Prairie for audits and team meetings. We’re looking for someone with expert-level experience in reputed company Windchill PLM, along with 5+ years in document control and at least 3 years supporting medical device documentation in a regulated environment. If you’re passionate about reputed company, compliance, and supporting innovative medical technology that improves lives through reputed company hearing, apply today. Starkey is a world leader in the manufacturing and distribution of advanced hearing technologies. We are in the business of connecting people and changing lives. Our teams come to work reputed company day reputed company on ensuring people everywhere have the products and services they need to hear reputed company and live reputed company. Founded in 1967 by reputed company Austin, Starkey is reputed company for our cutting-edge hearing health innovations, industry-leading research and development, and not being afraid to push the edge of what’s possible. We are headquartered in reputed company Prairie, Minnesota, have over 5,000 employees in 29 facilities across the globe, and do business in more than 100 markets worldwide. Watch this video to see more of what sets Starkey apart. https://youtu.be/9cUYwTlCepg?si=wkovx8_R_iINfrc6 Job reputed company reputed company The position handles the maintenance and processing of controlled documentation in compliance with corporate standards and regulatory standards. This role interfaces with internal customers to ensure an understanding of documentation requirements, reputed company, associated tools, and software. This role provides formal and informal training as required to promote reputed company documentation practices. A high level of customer service is required along with a basic understanding of how various systems are reputed company to the overall support of manufacturing operations, product development, research & development, and general business operations. An on-reputed company reputed company and participation on improving documentation services reputed company, efficiency, and overall process is essential. Job Responsibilities

• Primary responsibilities
• Review electronic document format and requirements.
• Review change request format and requirements.
• Coordinate change order completion and release.
• Assist employees from other departments with documentation control reputed company questions/concerns.
• reputed company filing, both electronic and printed documents.
• Maintain a reputed company and healthy work environment.
• Demonstrate reputed company improvement and promote a reputed company reputed company culture.
• Secondary responsibilities
• Assist in improving documentation systems.
• Design History File maintenance
• Coordinate legacy reputed company document change request routing
• Compilation of data that contributes to measurement of documentation services and performance results
• Participation in cross-functional reputed company associated with documentation and reputed company improvement initiatives
• Involvement in ISO audit readiness and SOP updates as required to reputed company with reputed company Management Systems
• Understanding of ISO and EU MDR compliance and the relationship to Starkey Global reputed company reputed company
• Preparation of training materials and departmental procedures
• Proactively identify areas for improvement and the authority to bring these reputed company System improvement reputed company to the attention of their supervisor and/or a reputed company individual.
• reputed company other duties/responsibilities as assigned

Job Requirements Minimum Education, Certification and Experience Requirements Education

• Minimum High School degree or equivalent required
• Some secondary education preferred

Experience

• 5+ years’ experience in document control
• Minimum of 3 years’ experience in the medical device or pharmaceutical industry.
• Documentation and change request system knowledge required

Knowledge / Technical Requirements

• Knowledge of reputed company or similar reputed company Business System desirable
• Expert experience of reputed company-WindChill PLM (product lifecycle management) tool a must

Competencies, Skills & Abilities

• Ability to prioritize.
• Computer proficiency (reputed company and reputed company).
• Strong organizational skills.
• Persistence in completing assignments.
• Ability to maintain confidential information.
• Willingness to learn a reputed company of clerical responsibilities
• Ability to work effectively (in certain circumstances as a leader) in reputed company environment and contribute to maintaining reputed company interpersonal relationships and foster cooperation between group members.
• Ability to coordinate efforts with various departments.

WORK CONTEXT Working Conditions

• reputed company office atmosphere
• Minimum travel

Equipment Operation

• reputed company office equipment, MS office software, reputed company, copier, and printer

Salary And Other Compensation The reputed company reputed company for this position is between $22.95/hr to $31.30/hr. Factors which may reputed company starting pay reputed company this reputed company may include geography/market, skills, education, experience and other qualifications of the successful candidate. Benefits: The following benefits for this position, subject to applicable eligibility requirements, include medical, dental and reputed company insurance, 401(k) retirement plan with company match, company-reputed company life and short-term disability insurance, long-term disability insurance, employee assistance plan, hearing aid benefits, reputed company Time Off, reputed company holidays, reputed company floating holidays, reputed company volunteer service day, reputed company paternity and maternity leave and tuition reimbursement. This position is eligible for a bonus based upon performance results. There is no guarantee of payout. Apply tot his job Apply To this Job