Description:
The Senior Quality Management System & Document Control Specialist is responsible for administering and maintaining the company's QMS & Document Control systems to ensure the integrity, accuracy, accessibility, and compliance of controlled documentation throughout its lifecycle. This role serves as the subject matter expert for Quality Management & Document Control processes and supports Quality, Engineering, Manufacturing, Operations, Facilities, and other departments by managing controlled documents, engineering change documentation, quality records, and document workflows.
The Senior QMS & Document Control Specialist ensures compliance with applicable quality management system requirements, customer requirements, regulatory standards, and internal procedures while supporting continuous improvement initiatives.
Essential Responsibilities
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Administer and maintain the company's QMS and Electronic Document Management System (EDMS) and document control processes.
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Create, review, route, publish, revise, archive, and retire controlled documents including:
- Standard Operating Procedures (SOPs),
- Work Instructions,
- Policies,
- Forms,
- Specifications,
- Engineering drawings,
- Manufacturing procedures,
- Test methods,
- Quality manuals.
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Coordinate document review and approval workflows with document owners and functional leadership.
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Maintain document revision history and ensure only current approved versions are available for use.
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Manage Engineering Change Orders (ECOs), Engineering Change Notices (ECNs), and document revisions in accordance with established procedures.
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Ensure timely implementation of engineering and quality document changes throughout the organization.
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Maintain document retention and archival processes in accordance with company policy and regulatory requirements.
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Conduct periodic audits of controlled documentation to ensure accuracy, completeness, and compliance.
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Support internal audits, customer audits, certification audits, and regulatory inspections by providing requested documentation and records.
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Monitor document control metrics and recommend process improvements to increase efficiency and compliance.
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Develop and maintain document control procedures, templates, naming conventions, and document standards.
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Train employees on document control policies, procedures, and document management systems.
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Work closely with Engineering, Manufacturing, Quality, Supply Chain, Facilities, EHS, and Operations to ensure document accuracy and consistency.
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Assist with implementation and continuous improvement of Quality Management System documentation.
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Maintain confidentiality of proprietary, technical, and company-sensitive information.
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Perform other duties as assigned
Work Environment
This position is primarily performed in an office environment with frequent interaction with manufacturing, engineering, laboratory, and cleanroom personnel. The position requires regular movement between office and ( 10 % ) cleanroom/production areas to support document control activities, audits, and engineering change implementation
Occasional work outside normal business hours may be required to support production schedules, audits, or business needs.
Physical Demands
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The employee is regularly required to:
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Sit for extended periods while working on a computer
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Use hands and fingers to operate computers and office equipment.
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Communicate effectively verbally and in writing.
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Occasionally stand, walk, bend, reach, and lift or move materials weighing up to 20 pounds.
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Travel throughout office, cleanroom, and production facilities as needed.
Requirements:
- Associate degree in Business Administration, Quality, Engineering Technology, Technical Communications, or a related field; equivalent experience may be considered.
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Minimum of five (5) years of document control experience in a regulated manufacturing environment.
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Minimum of three (3) years supporting Quality Management Systems.
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Experience managing engineering documentation and revision control.
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Experience supporting Engineering Change Orders (ECOs) and document change processes.
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Experience with electronic document management systems (EDMS).
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Proficiency with Microsoft Office applications.
Preferred Education and Experience
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Bachelor's degree in Business, Engineering, Quality, Information Management, or a related discipline.
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Seven (7) or more years of document control experience in semiconductor, photonics, aerospace, medical device, or other high-technology manufacturing environments.
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Experience administering PLM, ERP, or QMS software systems.
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Experience planning and supporting ISO 9001, AS9100, ISO 13485, ISO 14001 and ISO 45001 or IATF 16949 certification.
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Internal Auditor certification or Lead Auditor training.
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Ability to track and close CAPA, NCR, RMA, SCAR, and Supplier Quality documents, Quality action items, and Document revisions/approvals.
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KPI and Quality Report generation and tracking.
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Experience with continuous improvement methodologies such as Lean Manufacturing or Six Sigma.
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Experience developing document control procedures and leading process improvement initiatives.
Successful candidates should demonstrate:
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Extensive knowledge of QMS & Document Control principles and best practices.
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Strong understanding of Quality Management Systems (QMS).
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Knowledge of ISO 9001 requirements; familiarity with AS9100, ISO 14001 or ISO 45001.
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Experience supporting engineering change management processes.
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Excellent organizational and time management skills.
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Exceptional attention to detail and accuracy.
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Strong written and verbal communication skills.
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Ability to prioritize multiple projects in a fast-paced manufacturing environment.
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Excellent problem-solving and analytical skills.
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Ability to work independently with minimal supervision.
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Strong customer service mindset and ability to build effective cross-functional relationships.
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High level of integrity and discretion with confidential information.
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Advanced proficiency with Microsoft Office applications, including Word, Excel, Outlook, and Teams.
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Experience using document management, PLM, ERP, or quality management software.
Work Authorization/Security Clearance Requirements
None
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the job. Duties, responsibilities, and activities may change at any time with or without notice at the discretion of the company.
Affirmative Action/EEO Statement
The employment policy of Skorpios is to provide equal opportunity to all individuals. Employment decisions are based on merit and business needs. It is the policy of this Company not to discriminate against any employee, or applicant for employment, because of age, sex (including pregnancy, perceived pregnancy, childbirth, breastfeeding, or related medical conditions), color, race, creed, national origin, religious persuasion (including religious dress and grooming practices), marital status, sexual orientation, gender identity, political belief, genetics, disability that does not prohibit performance of essential job functions with or without reasonable accommodations, medical condition, or any other protected characteristic under applicable federal, state, or local laws. Skorpios also does not discriminate on the basis of national origin or citizenship status, as provided under the Immigration Reform and Control Act of 1986.
