Documentation Specialist II
Starkey Inc, Eden Prairie, MN, United States
Documentation Specialist II
Starkey is hiring a Documentation Specialist II for our Global Headquarters in Eden Prairie, MN. This role is primarily remote, with occasional time required to be onsite in Eden Prairie for audits and team meetings. We're looking for someone with expert-level experience in PTC 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 quality, compliance, and supporting innovative medical technology that improves lives through better 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 each day focused on ensuring people everywhere have the products and services they need to hear better and live better. Founded in 1967 by Bill Austin, Starkey is known 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 Eden Prairie, Minnesota, have over 5,000 employees in 29 facilities across the globe, and do business in more than 100 markets worldwide. 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, methods, associated tools, and software. This role provides formal and informal training as required to promote proper documentation practices. A high level of customer service is required along with a basic understanding of how various systems are related to the overall support of manufacturing operations, product development, research & development, and general business operations. An on-going focus and participation on improving documentation services quality, efficiency, and overall process is essential. Primary responsibilities include: 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 related questions/concerns. Perform filing, both electronic and printed documents. Maintain a safe and healthy work environment. Demonstrate continuous improvement and promote a progressive quality culture. Secondary responsibilities include: Assist in improving documentation systems. Design History File maintenance Coordinate legacy paper document change request routing Compilation of data that contributes to measurement of documentation services and performance results Participation in cross-functional projects associated with documentation and continuous improvement initiatives Involvement in ISO audit readiness and SOP updates as required to comply with Quality Management Systems Understanding of ISO and EU MDR compliance and the relationship to Starkey Global Quality Manual Preparation of training materials and departmental procedures Proactively identify areas for improvement and the authority to bring these Quality System improvement ideas to the attention of their supervisor and/or a Quality individual. Perform other duties/responsibilities as assigned Minimum Education, Certification and Experience Requirements: Minimum High School degree or equivalent required Some secondary education preferred 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 Oracle or similar Enterprise Business System desirable Expert experience of PTC-WindChill PLM (product lifecycle management) tool a must Competencies, Skills & Abilities: Ability to prioritize. Computer proficiency (MS Word and Access). Strong organizational skills. Persistence in completing assignments. Ability to maintain confidential information. Willingness to learn a variety of clerical responsibilities Ability to work effectively (in certain circumstances as a leader) in a team environment and contribute to maintaining positive interpersonal relationships and foster cooperation between group members. Ability to coordinate efforts with various departments. Working Conditions: Standard office atmosphere Minimum travel Equipment Operation: Standard office equipment, MS office software, scanner, copier, and printer Salary and Other Compensation: The target rate for this position is between $22.95/hr to $31.30/hr. Factors which may affect starting pay within this range 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 vision insurance, 401(k) retirement plan with company match, company-paid life and short-term disability insurance, long-term disability insurance, employee assistance plan, hearing aid benefits, Paid Time Off, paid holidays, paid floating holidays, paid volunteer service day, paid paternity and maternity leave and tuition reimbursement. This position is eligible for a bonus based upon performance results. There is no guarantee of payout. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
Starkey is hiring a Documentation Specialist II for our Global Headquarters in Eden Prairie, MN. This role is primarily remote, with occasional time required to be onsite in Eden Prairie for audits and team meetings. We're looking for someone with expert-level experience in PTC 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 quality, compliance, and supporting innovative medical technology that improves lives through better 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 each day focused on ensuring people everywhere have the products and services they need to hear better and live better. Founded in 1967 by Bill Austin, Starkey is known 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 Eden Prairie, Minnesota, have over 5,000 employees in 29 facilities across the globe, and do business in more than 100 markets worldwide. 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, methods, associated tools, and software. This role provides formal and informal training as required to promote proper documentation practices. A high level of customer service is required along with a basic understanding of how various systems are related to the overall support of manufacturing operations, product development, research & development, and general business operations. An on-going focus and participation on improving documentation services quality, efficiency, and overall process is essential. Primary responsibilities include: 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 related questions/concerns. Perform filing, both electronic and printed documents. Maintain a safe and healthy work environment. Demonstrate continuous improvement and promote a progressive quality culture. Secondary responsibilities include: Assist in improving documentation systems. Design History File maintenance Coordinate legacy paper document change request routing Compilation of data that contributes to measurement of documentation services and performance results Participation in cross-functional projects associated with documentation and continuous improvement initiatives Involvement in ISO audit readiness and SOP updates as required to comply with Quality Management Systems Understanding of ISO and EU MDR compliance and the relationship to Starkey Global Quality Manual Preparation of training materials and departmental procedures Proactively identify areas for improvement and the authority to bring these Quality System improvement ideas to the attention of their supervisor and/or a Quality individual. Perform other duties/responsibilities as assigned Minimum Education, Certification and Experience Requirements: Minimum High School degree or equivalent required Some secondary education preferred 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 Oracle or similar Enterprise Business System desirable Expert experience of PTC-WindChill PLM (product lifecycle management) tool a must Competencies, Skills & Abilities: Ability to prioritize. Computer proficiency (MS Word and Access). Strong organizational skills. Persistence in completing assignments. Ability to maintain confidential information. Willingness to learn a variety of clerical responsibilities Ability to work effectively (in certain circumstances as a leader) in a team environment and contribute to maintaining positive interpersonal relationships and foster cooperation between group members. Ability to coordinate efforts with various departments. Working Conditions: Standard office atmosphere Minimum travel Equipment Operation: Standard office equipment, MS office software, scanner, copier, and printer Salary and Other Compensation: The target rate for this position is between $22.95/hr to $31.30/hr. Factors which may affect starting pay within this range 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 vision insurance, 401(k) retirement plan with company match, company-paid life and short-term disability insurance, long-term disability insurance, employee assistance plan, hearing aid benefits, Paid Time Off, paid holidays, paid floating holidays, paid volunteer service day, paid paternity and maternity leave and tuition reimbursement. This position is eligible for a bonus based upon performance results. There is no guarantee of payout. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.