Quality Systems Specialist

Quality Systems SpecialistAs a ProMed employee, you will contribute to the manufacture of products that have a significant impact on people's lives. Through honesty, integrity, and collaboration, we strive to be the very best as we hire the very best.ProMed was founded in 1989 addressing an industry need for cleanroom manufacturing of silicone components, specifically those having a medical application. We treat every component and finished device as though it will be used by a beloved family member or friend. We are dedicated to our customers and to our employees while helping to improve the health and well-being of people around the world.Working as one to help many.Why This Role MattersThe Quality Systems Specialist is responsible for the day-to-day administration, maintenance, and continuous improvement of document control within the Quality Management System (QMS), ensuring QMS components are accurate, current, properly revised, approved, accessible, and archived in compliance with regulatory requirements for the pharmaceutical and medical device industries. This position exercises independent quality judgment on decisions affecting ProMed's manufacturing activities. The Quality Systems Specialist supports ProMed's mission and values by applying and reinforcing the company's brand, philosophy, systems, policies, and procedures are consistently applied and upheld in all aspects of their work.What You'll AchieveYou'll ensure ProMed's Quality Management System remains accurate, current, and audit-ready by maintaining tight control over the lifecycle of every controlled document — from creation through revision, approval, distribution, and archiving. Your work will keep the organization compliant with ISO 13485, FDA 21 CFR 820, and 21 CFR Part 11, while driving continuous improvements that strengthen the QMS and support manufacturing operations.How You'll Achieve ItDocument Control OperationsAdminister the day-to-day operations of the document control system, including issuance, revision, approval routing, and archiving of controlled documents (SOPs, work instructions, forms, specifications, and quality records)Maintain document master lists and revision histories to ensure all controlled documents reflect the current approved versionManage physical and/or hybrid document distribution, including retrieval and destruction of obsolete documents from points of useAssign and maintain document numbering schemes, version control conventions, and document retention schedules consistent with site SOPs and regulatory requirementsEnsure document templates are standardized, current, and compliant with applicable regulatory and quality standardsManage electronic and physical document repositoriesChange & Review ManagementProcess document change requests, track change history, and support change impact assessments in collaboration with subject matter experts (SMEs)Oversee the creation, review, approval, and distribution of controlled documents — including SOPs, policies, forms, and work instructions — in accordance with ALCOA principlesSupport the periodic review process for controlled documents, notifying document owners of upcoming review dates and coordinating timely completionCoordinate training assignments for new and revised documents, ensuring training records are completed and filed in a timely mannerCompliance & Regulatory AdherenceMaintain documentation files in compliance with ISO 13485, FDA 21 CFR 820, and 21 CFR Part 11Input data to create and revise material and method masters in the ERP systemQuality Decision-Making & Continuous ImprovementMake independent quality decisions and notify management of actions takenIdentify, propose, and implement quality process and system improvementsInvestigate and resolve complex technical issues using strong problem-solving skillsOther ResponsibilitiesIdentify and escalate gaps, inconsistencies, or potential compliance risks within the QMS to the QA ManagerParticipate in internal audits and self-inspections as assigned; support corrective action follow-up activitiesSupport the implementation of regulatory changes and quality system improvements as directedAssist in preparing responses to audit observations or regulatory findings involving document or records managementNecessary Skills:To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Bachelor's degree in Life Sciences, Chemistry, Engineering, or a related field;2-5 years of experience in a regulated industry (pharma, biotech, or medical device);Working knowledge of GMP principles, ISO 13485 and FDA regulatory requirements (21 CFR Parts 210/211 and/or 820);Proficiency in Microsoft Office Suite (Word, Excel, Outlook).Preferred:Familiarity with eQMS platforms (e.g., MasterControl, Veeva Vault, Agile) even if primary system is paper-based;Experience with ISO 13485 quality management principles;Knowledge of ALCOA+ data integrity principles;Ability to work autonomously, effectively manage time and deliver results on time;Attention to detail and commitment to data integrity and accuracy in all quality records;Effective written and verbal communication skills; ability to clearly document processes, decisions, and deviations;Minimum Qualifications For The Role:Bachelor's degree in Life Sciences, Chemistry, Engineering, or a related field;2-5 years of experience in a regulated industry (pharma, biotech, or medical device);Working knowledge of GMP principles, ISO 13485 and FDA regulatory requirements (21 CFR Parts 210/211 and/or 820);Proficiency in Microsoft Office Suite (Word, Excel, Outlook).Physical, Sensory, Cognitive & Neurological Demands:Work is performed indoors in a climate-controlled, ventilated facility with fluorescent lighting and generally minor noise levels; occasional exposure to chemical substances used for cleaning or equipment operation may occurRegularly required to stand, walk, sit, stoop, bend, squat, kneel, reach, and use repetitive motions; occasionally required to move quickly and navigate smooth or uneven surfaces, including tight spaces between desks and workstationsFrequently required to grasp and manipulate objects such as pens, markers, scissors, staplers, and whiteboard tools, which may involve reaching at, below, or above shoulder height and occasional trunk or neck rotationMay be required to exert approximately 25+ pounds of force to push or pull equipment such as computers, overhead projectors, or televisionsRequires close vision (e.g., reading handwritten or typed material) and the ability to adjust visual focusMust be able to see, hear, and speak continuously to frequently in order to communicate effectivelyMust be able to manage multiple, simultaneous demands from various internal and external stakeholdersRequires ongoing interaction and communication with employees, management, and external contacts across the organizationHow Your Success Will Be Measured:Your Key Performance Indicators:Document Turnaround Time — Percentage of document change requests (creation, revision, approval) processed within established SLA timeframesOn-Time Periodic Review Completion — Percentage of controlled documents reviewed and updated by their scheduled review date, with no overdue reviews exceeding site-defined thresholdsAudit & Inspection Readiness — Number of document control-related findings or observations identified during internal audits, external audits, or regulatory inspectionsTraining Compliance Rate — Percentage of employees who complete required training on new or revised documents within the designated timeframeData Integrity & Accuracy — Accuracy rate of document control records (numbering, versioning, master lists) as measured through periodic internal reviews or audits, with minimal discrepancies identifiedExpected Competencies:Competency - ExplanationAttention to Detail - Consistently ensures accuracy and completeness in document control records, quality records, and compliance documentationRegulatory & Quality Systems Knowledge - Applies working knowledge of ISO 13485, FDA 21 CFR