Assoc Quality Systems Spec

Pay 40-50/h depending on experience

HM’s Top Needs:

Education Required: Bachelor’s degree

Years’ Experience

Required:

Minimum 2 years of relevant experience preferred.

Hours per Week: 40 hours/week

Work Location: Rice Creek

Do they need to be local to an MDT office? Yes

Does this person need to be onsite? Yes

The Associate Quality Systems Specialist supports site closure activities by processing change orders, executing where-used assessments, coordinating documentation updates, and ensuring timely implementation of quality system changes in compliance with company procedures and regulatory requirements.

• Process change orders associated with site closure and quality system inactivation activities.
• Execute where-used assessments to identify impacted procedures, forms, specifications, records, and quality system documents.
• Coordinate document updates and obsolescence activities required for site closure.
• Support impact assessments and implementation of approved changes.
• Track change order progress and ensure completion within established timelines.
• Collaborate with cross-functional stakeholders including Quality, Operations, Engineering, Regulatory Affairs, and Document Control.
• Maintain accurate records within the electronic Quality Management System (eQMS).
• Support project reporting and status updates for site closure activities.
• Ensure compliance with internal quality system requirements and applicable regulations.

• Requires broad theoretical job knowledge typically obtained through advanced education.
• Requires a Baccalaureate degree (or, for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A)).
• 0 years of experience required.

• Internship, co-op, or academic project experience in Quality, Manufacturing, Engineering, Regulatory Affairs, or Document Control.
• Experience working in a regulated environment such as Medical Device, Pharmaceutical, Biotechnology, or Manufacturing.
• Familiarity with quality systems and document control processes.
• Experience with electronic quality management systems (eQMS) is a plus.

• Strong attention to detail.
• Excellent organizational and time management skills.
• Ability to manage multiple assignments and meet deadlines.
• Strong written and verbal communication skills.
• Proficient in Microsoft Office applications.
• Ability to analyze information and identify document impacts across quality systems.
• Ability to work independently and collaboratively within cross-functional teams.