Assoc Quality Systems Spec - Exempt

HM's Top Needs:

1. Experience with Change Control / Change Order processing in a regulated environment.
2. Experience performing document impact assessments and where-used reviews.
3. Experience with Quality Systems, Document Control, or eQMS processes (Like Agile MAP) within Medical Device, Pharmaceutical, Biotechnology, or other regulated industries.

ducation Required: Bachelor's degreetr

Years' Experience Required: Minimum 2 years of relevant experience preferred.

Hours per Week: 40 hours/week

Work Location: Rice Creek, MN

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.

Essential Responsibilities

• 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.

Required Knowledge and Experience

• 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.

Preferred Qualifications

• 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.

Key Skills

• 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.
  
  
  
  
  Responsibilities may include the following and other duties may be assigned. Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines. Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance. Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations. Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits. Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external. Co-ordinates legal requests in support of government investigations or litigations. Ensures the quality assurance programs and policies are maintained and modified regularly. Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects – from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education. DIFFERENTIATING FACTORS Autonomy: Entry-level individual contributor on a project or work team. Works with close supervision. Organizational Impact: Delivers work of limited scope, typically smaller, less complex projects or related activities. Innovation and Complexity: Identifies, defines and addresses problems that are not immediately evident but typically not difficult or complex. Makes minor changes in systems and processes to solve problems . Communication and Influence: Communicates primarily with internal contacts within immediate group. Contacts others to gather, confirm and convey information. Leadership and Talent Management: N / A – job at this level is focused on self-development . Required Knowledge and Experience: 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.