MicroSurgical Technology
Document Control Specialist
MicroSurgical Technology, Redmond, Washington, United States, 98052
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MicroSurgical Technology provided pay range
This range is provided by MicroSurgical Technology. Your actual pay will be based on your skills and experience talk with your recruiter to learn more. Base pay range
$65,000.00/yr - $80,000.00/yr Founded in 1976 and headquartered in Redmond, Washington, MicroSurgical Technology's passion is creating exceptional surgical devices and instruments used to restore or improve sight for patients all over the world. MST is part of UK based Halma PLC, a global company whose healthcare division helps provide technologies and solutions that enhance the quality of patients lives. Our products are surgeon-designed and meticulously crafted to instill confidence and assurance in Cataract and Glaucoma procedures and include a wide range of surgical instruments such as forceps, scissors, hooks, spatulas, and knives, all designed for the delicate and intricate procedures required in microsurgery. Together, we create a place where we are successful, motivated by our mission and inspire each other. This is where you can do your best work! Document Control Specialist Location Redmond, WA Job Summary: The Document Control Specialist is responsible for the administration and control of documents and records within the Quality Management System (QMS), ensuring compliance with applicable regulatory standards (e.g., FDA 21 CFR Part 820, ISO 13485, EU MDR). This position supports change control, elements of configuration management, and lifecycle control of design and manufacturing documentation. The role requires high attention to detail, strong organizational skills, and a deep understanding of document and change control principles in a highly regulated environment. Responsibilities: Manage the full lifecycle of controlled documents including creation, review, approval, release, revision, obsolescence, and archival. Ensure documentation complies with internal procedures and regulatory standards. Administer the electronic Quality Management System (eQMS), including maintaining metadata, audit trails, workflows, and user permissions. Share primary ownership of document & change control, as well as training administration. Provide controlled documents in support of internal and external audits, ensuring document readiness and traceability. Coordinate and process change orders in accordance with company procedures and regulatory expectations. Ensure change documentation is complete, accurate, and reviewed/approved by appropriate stakeholders. Monitor and support implementation of approved changes. Assist in the maintenance of configuration control of product documentation throughout its lifecycle (e.g., Design History Files, Device Master Records). Maintain and organize records in accordance with regulatory retention requirements and internal policies. Ensure accessibility, security, and legibility of both electronic records during their required retention periods. Serve as key user or administrator for the eQMS both from a document & change control standpoint, as well as training management. Train and support users in document control and change control processes and system usage. Identify and support process improvement initiatives related to document and configuration management. Support the creation and revision of ERP-controlled items such as part numbers, BOMs, and routers. Collaborate with cross-functional teams to ensure ERP changes are implemented accurately and consistently with documentation changes. Enter and validate data in ERP changes related to change orders. Performs other duties as necessary. Qualifications: Associate or Bachelor's degree in a technical, business, or administrative discipline, or equivalent experience. Minimum 3 years of experience in document control and/or configuration management in a highly regulated industry (e.g., medical device, pharmaceutical, aerospace). Knowledge of FDA QSR, ISO 13485, and document control principles. Experience with eQMS and ERP platforms. MasterControl and Infor Syteline is highly desirable, but other similar systems would be considered acceptable. Strong skills in using Microsoft Word, especially with understanding how to use its complex document formatting features. Experience in using Microsoft Teams, or other similar software such as Slack. Strong organizational skills, attention to detail, and ability to manage multiple document workflows. Strong communication (both written and oral) and interpersonal skills, with the ability to collaborate effectively with cross-functional teams. Demonstrated ability to work independently, prioritize tasks, and manage multiple projects simultaneously. Proven high aptitude for adoption of technology and ability to configure a software environment. Experience in using Project/Task Management Software is preferred. ClickUp is highly desirable, but other similar systems (e.g., Jira, Asana, Monday, etc..) would be acceptable. Prior experience assisting in internal and external audits is preferred. Salary Range: DOE $65-80k The salary range listed in this posting reflects the compensation for a successful candidate in the assigned geographic territory. The successful candidates actual pay will be based on various factors such as skills, qualifications and experience. This role is eligible for a competitive benefits package that includes medical, dental, vision, life, and disability insurance; 401K retirement plan; flexible spending and health savings account; paid holidays; paid time off; parental leave; employee assistance program and other company benefits. MicroSurgical Technology Inc. is an equal opportunity employer and does not discriminate based on gender, sex, age, race and color, religion, marital status, national origin, disability, sexual orientation, gender identity or expressions, veteran status, or any other category that is protected by applicable law. Please note that only qualified candidates will be contacted for further consideration. Seniority level
Seniority level
Mid-Senior level Employment type
Employment type
Full-time Job function
Job function
Quality Assurance and Manufacturing Industries
Medical Equipment Manufacturing Referrals increase your chances of interviewing at MicroSurgical Technology by 2x Get notified about new Document Control Specialist jobs in
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This range is provided by MicroSurgical Technology. Your actual pay will be based on your skills and experience talk with your recruiter to learn more. Base pay range
$65,000.00/yr - $80,000.00/yr Founded in 1976 and headquartered in Redmond, Washington, MicroSurgical Technology's passion is creating exceptional surgical devices and instruments used to restore or improve sight for patients all over the world. MST is part of UK based Halma PLC, a global company whose healthcare division helps provide technologies and solutions that enhance the quality of patients lives. Our products are surgeon-designed and meticulously crafted to instill confidence and assurance in Cataract and Glaucoma procedures and include a wide range of surgical instruments such as forceps, scissors, hooks, spatulas, and knives, all designed for the delicate and intricate procedures required in microsurgery. Together, we create a place where we are successful, motivated by our mission and inspire each other. This is where you can do your best work! Document Control Specialist Location Redmond, WA Job Summary: The Document Control Specialist is responsible for the administration and control of documents and records within the Quality Management System (QMS), ensuring compliance with applicable regulatory standards (e.g., FDA 21 CFR Part 820, ISO 13485, EU MDR). This position supports change control, elements of configuration management, and lifecycle control of design and manufacturing documentation. The role requires high attention to detail, strong organizational skills, and a deep understanding of document and change control principles in a highly regulated environment. Responsibilities: Manage the full lifecycle of controlled documents including creation, review, approval, release, revision, obsolescence, and archival. Ensure documentation complies with internal procedures and regulatory standards. Administer the electronic Quality Management System (eQMS), including maintaining metadata, audit trails, workflows, and user permissions. Share primary ownership of document & change control, as well as training administration. Provide controlled documents in support of internal and external audits, ensuring document readiness and traceability. Coordinate and process change orders in accordance with company procedures and regulatory expectations. Ensure change documentation is complete, accurate, and reviewed/approved by appropriate stakeholders. Monitor and support implementation of approved changes. Assist in the maintenance of configuration control of product documentation throughout its lifecycle (e.g., Design History Files, Device Master Records). Maintain and organize records in accordance with regulatory retention requirements and internal policies. Ensure accessibility, security, and legibility of both electronic records during their required retention periods. Serve as key user or administrator for the eQMS both from a document & change control standpoint, as well as training management. Train and support users in document control and change control processes and system usage. Identify and support process improvement initiatives related to document and configuration management. Support the creation and revision of ERP-controlled items such as part numbers, BOMs, and routers. Collaborate with cross-functional teams to ensure ERP changes are implemented accurately and consistently with documentation changes. Enter and validate data in ERP changes related to change orders. Performs other duties as necessary. Qualifications: Associate or Bachelor's degree in a technical, business, or administrative discipline, or equivalent experience. Minimum 3 years of experience in document control and/or configuration management in a highly regulated industry (e.g., medical device, pharmaceutical, aerospace). Knowledge of FDA QSR, ISO 13485, and document control principles. Experience with eQMS and ERP platforms. MasterControl and Infor Syteline is highly desirable, but other similar systems would be considered acceptable. Strong skills in using Microsoft Word, especially with understanding how to use its complex document formatting features. Experience in using Microsoft Teams, or other similar software such as Slack. Strong organizational skills, attention to detail, and ability to manage multiple document workflows. Strong communication (both written and oral) and interpersonal skills, with the ability to collaborate effectively with cross-functional teams. Demonstrated ability to work independently, prioritize tasks, and manage multiple projects simultaneously. Proven high aptitude for adoption of technology and ability to configure a software environment. Experience in using Project/Task Management Software is preferred. ClickUp is highly desirable, but other similar systems (e.g., Jira, Asana, Monday, etc..) would be acceptable. Prior experience assisting in internal and external audits is preferred. Salary Range: DOE $65-80k The salary range listed in this posting reflects the compensation for a successful candidate in the assigned geographic territory. The successful candidates actual pay will be based on various factors such as skills, qualifications and experience. This role is eligible for a competitive benefits package that includes medical, dental, vision, life, and disability insurance; 401K retirement plan; flexible spending and health savings account; paid holidays; paid time off; parental leave; employee assistance program and other company benefits. MicroSurgical Technology Inc. is an equal opportunity employer and does not discriminate based on gender, sex, age, race and color, religion, marital status, national origin, disability, sexual orientation, gender identity or expressions, veteran status, or any other category that is protected by applicable law. Please note that only qualified candidates will be contacted for further consideration. Seniority level
Seniority level
Mid-Senior level Employment type
Employment type
Full-time Job function
Job function
Quality Assurance and Manufacturing Industries
Medical Equipment Manufacturing Referrals increase your chances of interviewing at MicroSurgical Technology by 2x Get notified about new Document Control Specialist jobs in
Redmond, WA . Bellevue, WA $73,795.00-$110,692.00 10 months ago Redmond, WA $48,130.00-$65,000.00 4 days ago Seattle, WA $50,000.00-$107,100.00 1 week ago Executive Assistant, Returns and ReCommerce
Bellevue, WA $66,800.00-$142,800.00 1 week ago Seattle, WA $90,000.00-$115,000.00 1 week ago Executive Assistant to CEO (Tech Startup)
Seattle, WA $66,800.00-$142,800.00 1 week ago Seattle, WA $85,000.00-$95,000.00 2 days ago Seattle, WA $66,800.00-$142,800.00 3 days ago Bellevue, WA $50,000.00-$107,100.00 5 days ago Seattle, WA $80,000.00-$100,000.00 2 weeks ago Everett, WA $38,100.00-$60,700.00 2 weeks ago Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr