Top 12 Quality specialist Jobs in Delano Mn

Quality Documentation Control Specialist
PROMED MOLDED PRODUCTS INC —Plymouth, MN
- $29.68 - $40.96 an hour
- Full-time
- Microsoft Excel
- Microsoft Outlook
- ERP systems
Product Quality Specialist
Bora Pharmaceutical Services —Maple Grove, MN
- $74,000 - $95,000 a year
- Full-time
- Word processing
- Mid-level
- Bachelor's degree
- Health insurance
- Dental insurance
Quality Specialist III
Takeda Pharmaceutical —Brooklyn Park, MN
- $89,900 - $141,240 a year
- Full-time
- Microsoft Excel
- Bachelor of Science
- English
- Paid holidays
- Disability insurance
3d
Quality Control Specialist
ITG Communications —Chaska, MN
- $23.08 - $31.25 an hour
- Full-time
- Construction site
- Customer service
- Ability to walk for extended periods
Senior Clinical Quality Assurance Specialist
Boston Scientific —Maple Grove, MN
- $81,000 - $153,900 a year
- Hybrid work
- Office
- 3 years
- Continuous improvement
3h
Quality Systems & Metrology Specialist — Medical Device Components
TOMZ Manufacturing Corp —Big Lake, MN
- $23 - $29 an hour
- Computer literacy
- Basic math
- English
Quick Apply
7d
Loan and Deposit QA Specialist
Bridgewater Bank —Saint Louis Park, MN
- $27.70 - $30.90 an hour
- Hybrid work
- Writing skills
- Mid-level
- Bachelor's degree
- Paid holidays
- Disability insurance
Quick Apply
NDT Specialist - AUT, PAUT, Guided Wave - St. Louis Park, MN
Acuren Inspection, Inc. —Saint Louis Park, MN
- $34.75 - $57.91 an hour
- Full-time
- Management
- 5 years
- Mid-level
- Paid holidays
- Health insurance
Color Control Specialist
JAPS-OLSON COMPANY, LLC —Saint Louis Park, MN
- $22 - $30 an hour
- Pass drug screening
- Mid-level
- Bachelor's degree
- Paid parental leave
- Health savings account
Quick Apply
Mechanical Commissioning Specialist (Entry Level)
Emanuelson - Podas Inc —Minneapolis, MN
- $65,000 - $80,000 a year
- Construction site
- Office
- Ability to lift 50 pounds
Quick Apply
Sr Construction Services Specialist
AE2S —Maple Grove, MN
- $43.70 - $53.41 an hour
- Overtime
- Background check
- Construction site
- Ability to walk for extended periods
- Wellness program
- Health insurance

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Ability to lift/move up to 50 lbs and operate pallet jacks or forklifts (certification preferred). The ideal candidate has 2+ years of experience in purchasing,…
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Quality Documentation Control Specialist

PROMED MOLDED PRODUCTS INC
Plymouth, MN

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Job Details

Full-time
$29.68 - $40.96 an hour

Qualifications

Microsoft Excel
Microsoft Outlook
Pharmaceutical regulatory compliance
FDA 21 CFR Part 11
GMP
Biomedical regulatory compliance

Full Job Description

POSITION SUMMARY

The Quality Assurance Document Control Specialist is responsible for day-to-day administration, maintenance, and continuous improvement of the organization’s document control within the Quality Management System (QMS) in a regulated pharmaceutical and medical device environment. Ensuring that QMS components are accurate, current, revised, approved, accessible and archived in a compliant manner. The Quality Documentation Control Specialist ensures ProMed’s brand, philosophy, systems, policies, and procedures are properly implemented and observed.

ESSENTIAL DUTIES & RESPONSIBILITIES

Position duties and responsibilities include, but are not limited to the following:

Administer the 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 version;
Manage physical and/or hybrid document distribution, including retrieval and destruction of obsolete documents from points of use;
Process document change requests, track change history, and support change impact assessments in collaboration with subject matter experts (SMEs);
Assign and maintain document numbering schemes, version control conventions, and document retention schedules consistent with site SOPs and regulatory requirements;
Ensure document templates are standardized, current, and compliant with applicable regulatory and quality standards;
Oversee the creation, review, approval and distribution of controlled documents, including SOPs, policies, forms and work instructions with ALCOA principles;
Maintains the documentation files in compliance with ISO 13485. FDA 21 CFR 820
and 21 CFR Part 11;
Manage electronic and physical document repositories;
Support the periodic review process for controlled documents, notifying document owners of upcoming review dates and coordinating timely completion;
Coordinate training assignments for new and revised documents, ensuring training records are completed and filed in a timely manner as applicable;
Inputs data to create and revise material and method masters in the ERP system.

OTHER RESPONSIBILITIES

Identify and escalate gaps, inconsistencies, or potential compliance risks within the QMS to the QA Manager;
Participate in internal audits and self-inspections as assigned; support corrective action follow-up activities;
Support the implementation of regulatory changes and quality system improvements as directed;
Assist in preparing responses to audit observations or regulatory findings that involve document or records management.

QUALIFICATION, EDUCATION & EXPERIENCE

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.

Required:

Bachelor’s degree in Life Sciences, Chemistry, Engineering, or a related field;
0-2 years of experience in a regulated industry (pharma, biotech, or medical device);
Working knowledge of GMP principles 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;
Strong organizational skills with the ability to manage multiple priorities, deadlines, and document workflows simultaneously;
Collaborative mindset with the ability to work cross-functionally with operations, R&D, and other QA functions;
Comfort working in a structured, compliance-driven environment with defined SOPs and change control requirements;
Proactive problem-solving skills; escalates issues appropriately and follows through on assigned action items;
Aptitude for learning and applying regulatory requirements and quality standards.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the principal roles and responsibilities of this job:

Exposure to heated/air conditioned, ventilated facilities with florescent lighting;
Exposure to building where a variety of chemical substances are used for cleaning, and/or operation of equipment;
The noise level in the work environment is usually minor;
Duties are performed indoors;
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

PHYSICAL, SENSORY, COGNITIVE & NEUROLOGICAL DEMANDS

While performing the duties of this job:

The employee may be required to stoop, bend, squat, kneel, reach, stand, walk, lift, pull, push, grasp, talk, hear, see and use repetitive motions;
Specific vision abilities required include close vision such as to read handwritten or typed material and the ability to adjust focus;
The position requires the individual to meet multiple demands from several people and interact with internal and external people;
Employee moves about the building and be able to maneuver in tight spaces between desks, etc.;
Employee may have duties involving walking on even or uneven surfaces;
Employee occasionally to frequently use a whiteboard, which can require grasping whiteboard pens, reaching at, below, or above shoulder height and may require trunk or neck rotation to look back;
Employee may use computers, overhead projectors, TV, and other work-related equipment, which may require an approximately 25+ pound force to push or pull equipment;
It is necessary to grasp and manipulate pens, markers, scissors, staplers, etc. occasionally to frequently;
Employee must see and hear on a continuous basis as well as speak frequently;
Position varies from standing, sitting, walking, etc. On some occasions it may be necessary to move quickly, run, etc. over smooth or uneven surfaces.

1st Shift

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Refine Your Search

quality specialist jobs in delano mn

Quality Documentation Control Specialist

Product Quality Specialist

Quality Specialist III

Quality Control Specialist

Senior Clinical Quality Assurance Specialist

Quality Systems & Metrology Specialist — Medical Device Components

Loan and Deposit QA Specialist

NDT Specialist - AUT, PAUT, Guided Wave - St. Louis Park, MN

Color Control Specialist

Mechanical Commissioning Specialist (Entry Level)

Sr Construction Services Specialist

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