Quality Systems Specialist II

Summary

The Quality Systems Specialist II supports key quality system activities with a primary focus on Engineering Change Management (ECOs) and the documentation processes that support production and product changes. This role helps ensure changes are properly reviewed, approved, implemented, and documented in a timely and controlled manner.

In addition to change management, this position supports document control, label management, and job document review and closure. The role works closely with Quality, Engineering, Operations, and Production to keep documentation accurate, current, and aligned with internal procedures and regulatory requirements, including ISO 13485:2016 and FDA 21 CFR Part 820.

Duties / Responsibilities

• Coordinate Engineering Change Orders (ECOs) from initiation through implementation and closure, ensuring required documentation and approvals are complete and on time.
• Review change requests and related documentation for accuracy, completeness, and impact to controlled documents such as specifications, work instructions, bills of material, and forms.
• Support document control activities, including document revisions, routing, release, obsolescence, and record maintenance within the eQMS.
• Support label management by coordinating label revisions, reviews, approvals, and release of approved labeling content.
• Review job documentation for completeness, correct revision levels, and alignment to approved requirements before release or closure.
• Work with cross-functional teams to resolve documentation gaps, missing approvals, or discrepancies that could delay change implementation or job closure.
• Maintain logs and status trackers for ECOs, document revisions, label updates, and job closure activities.
• Support continuous improvement of change control and documentation processes while maintaining compliance with internal procedures and regulatory requirements.

Accountabilities

• Timely coordination and closure of Engineering Change Orders.
• Accurate and complete review of documents affected by engineering changes.
• Effective support of document control and labeling processes to ensure current, approved documents are available for use.
• Thorough review and timely closure of job documentation.
• Clear cross-functional follow-up to prevent delays in document updates and implementation activities.
• Maintenance of complete and audit-ready records within the eQMS.
• Compliance with Quality Management System procedures, document control requirements, and applicable regulatory standards.

Training/Education/Experience:

• High School education or equivalent and 2 years of trade school in technical field or equivalent work experience.
• 3+ years of experience in a regulated manufacturing environment, preferably in medical device, pharmaceutical, or other highly controlled industries.
• Experience supporting engineering change management, document control, and/or quality systems processes within an eQMS, ERP, PLM, or similar system.
• Working knowledge of ISO 13485, FDA 21 CFR Part 820, Good Documentation Practices, and general controlled document requirements.
• Experience reviewing and maintaining controlled documents such as procedures, work instructions, specifications, bills of material, forms, and labeling records preferred.
• Strong attention to detail, organizational skills, and ability to manage multiple priorities while working effectively across Quality, Engineering, and Operations.

Competencies/Talents/Personal Attributes:

• Excellent communication skills, written and verbal with ability to consistently comply with documentation requirements.
• Demonstrates initiative and independence: Proactively seeks new opportunities and exhibits self-confidence, is action oriented and makes things happen, despite apparent roadblocks.
• Consistently demonstrates a positive professional demeanor and level-headedness, able to work through tight timelines, development challenges, and frequent change requests without losing composure, and able to work cooperatively and supportive with customers, sales, engineering, quality, and production.
• Demonstrates organization, planning, and follow-through: Plans, organizes, and schedules efficiently. Effectively manages multiple projects, establishes contingencies, delivers on promises, and completes the required documentation.
• Strong applied math skills with ability to calculate material consumption and machine settings.
• Demonstrates a commitment to comply with ISO13485 and FDA regulations.
• Ability to read blueprints and to understand geometric dimensioning and tolerances.
• Ability to work effectively on computers, to collect data, to create graphs, to create process flow diagrams, and to create press diagrams.
• Can speak, understand and write English