Quality Assurance Specialist

1 week ago

Itasca, United States Organ Recovery Systems, Inc. Full time

We're looking for a Quality Assurance Specialist to join our team and support the Organ Transplant Community with high quality, innovative medical devices. The Quality Assurance Specialist is responsible for the maintenance of the Quality Management System in accordance with FDA Quality Systems Regulations, ISO 13485 and other applicable country specific regulations. Specifically, this role supports the manufacture, testing, and release of products using controlled processes to assure that they meet all customer and regulatory requirements.

**PRIMARY FUNCTIONS**:
**1. Coordinate** review and release of product batches to ensure compliance to customer and regulatory requirements.
- Review manufacturing and testing documentation for accuracy and completeness.
- Generate Certificates of Compliance.

**2. Support and/or Coordinate **Document Control for product and process change management.
- Review change requests for accuracy and completeness.
- Track change implementation and training.

**3. Support **Complaint Handling program.
- Investigate customer complaints to identify root cause.
- Perform entry and analysis of complaint and repair data.
- Interface with Customer Service to ensure cases are closed in a timely manner.

**4. Support **Internal Audit program.
- Execute internal audits per schedule.
- Implement corrective actions to address audit observations.

**QUALIFICATIONS**:
**Education/Training/ Certifications/Licenses**:

- Bachelor’s Degree in a scientific or engineering field

OR
- 5+ years of experience in medical device or pharmaceutical Quality Assurance.

**Experience**:

- 2+ years of relevant industry experience.

**Skills/Abilities**:

- Strong communication skills with the ability to address all levels within the organization
- Strong computer skills (Excel, Word, PowerPoint)
- Flexible; able to multi-task different projects and priorities.
- Ability to interact effectively to accomplish objectives with multiple departments.

**Physical Demands**:
Strength/Bend/Lift: Able to bend and lift up to 25 pounds

Sit/Stand %s: Sitting 90%, Standing 10%

Manual Dexterity: Not applicable

Work Environment: Normal office environment

Travel: < 10% travel including air and overnight travel; Occasional local travel by car.

Hours: Approx. 40 hours per week, occasional overtime including weekends

Pay: $60,000.00 - $80,000.00 per year

**Benefits**:

- 401(k)
- 401(k) matching
- Dental insurance
- Flexible schedule
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Vision insurance

Schedule:

- 8 hour shift

Supplemental pay types:

- Bonus opportunities

**Education**:

- Bachelor's (required)

**Experience**:

- Quality Assurance or Quality Control: 2 years (required)

Work Location: In person

  • Quality Assurance Specialist

    3 weeks ago

    Itasca, United States Topco Associates LLC Full time

    OverviewTopco Associates is currently seeking a Quality Assurance Specialist - Product Management for the Quality Assurance team in Itasca, IL. This position will be a hybrid role, with the successful candidate conducting work in our Itasca office and virtually. Under guidance of QA management, promotes the delivery of optimal QA services and standards by...

  • Quality Assurance Specialist

    4 weeks ago

    Itasca, United States Topco Associates LLC Full time

    OverviewTopco Associates is currently seeking a Quality Assurance Specialist - Product Management for the Quality Assurance team in Itasca, IL. This position will be a hybrid role, with the successful candidate conducting work in our Itasca office and virtually. Under guidance of QA management, promotes the delivery of optimal QA services and standards by...

  • Quality Assurance Specialist

    3 weeks ago

    Itasca, United States Topco Associates LLC Full time

    OverviewTopco Associates is currently seeking a Quality Assurance Specialist - Product Management for the Quality Assurance team in Itasca, IL. This position will be a hybrid role, with the successful candidate conducting work in our Itasca office and virtually. Under guidance of QA management, promotes the delivery of optimal QA services and standards by...

  • Quality Assurance Specialist

    1 month ago

    Itasca, United States Topco Associates LLC Full time

    OverviewTopco Associates is currently seeking a Quality Assurance Specialist - Product Management for the Quality Assurance team in Itasca, IL. This position will be a hybrid role, with the successful candidate conducting work in our Itasca office and virtually. Under guidance of QA management, promotes the delivery of optimal QA services and standards by...

  • Quality Assurance Manager

    2 months ago

    Itasca, United States NCAB Group Full time

    THIS IS NCAB GROUP: We are a leading global PCB supplier founded in 1993. Today, we have local presence in 15 countries in Europe, Asia and North America and customers in approximately 45 countries worldwide. Revenue in 2022 amounted to 440,000,000 USD. **Quality Assurance Manager**: **What you will do**: - Oversee the internal quality assurance system. -...

  • Quality Assurance Coordinator

    3 weeks ago

    Itasca, United States Hearthside Food Solutions Full time

    Founded in 2009 and headquartered in Downers Grove, IL we are a world-class contract manufacturer producing wholesome baked goods, snacks and packaged foods for many of the world’s leading food companies. As one of the largest and fastest growing food co-manufacturing companies in the US, we are the proud owner and operator of over 35 facilities globally....

  • Assurance Manager

    1 month ago

    Itasca, United States CDH, P.C. Full time

    We're seeking an Assurance Manager to join our team, responsible for managing the operations of our Assurance department. This role entails overseeing staff, ensuring project service excellence, and delivering top-notch assurance and review engagements. The ideal candidate will possess audit expertise, particularly in Employee Benefit Plans and Manufacturing...

  • Assurance Manager

    3 weeks ago

    Itasca, United States Illinois CPA Society Full time

    We're seeking an Assurance Manager to join our team, responsible for managing the operations of our Assurance department. This role entails overseeing staff, ensuring project service excellence, and delivering top-notch assurance and review engagements. The ideal candidate will possess audit expertise, particularly in Employee Benefit Plans and Manufacturing...

  • Quality Assurance Manager

    4 weeks ago

    Itasca, United States Sterling Engineering Full time

    Sterling Engineering is a growing engineering and staffing services firm that specializes in placing top engineering and technical talent into their dream jobs. We have partnered with a leading manufacturer near Schaumburg on bringing in a Quality Manager to join their growing team. This person will be a "change agent" in the quality space. Why Work Here?...

  • Quality Assurance Manager

    4 weeks ago

    Itasca, United States Sterling Engineering Full time

    Sterling Engineering is a growing engineering and staffing services firm that specializes in placing top engineering and technical talent into their dream jobs. We have partnered with a leading manufacturer near Schaumburg on bringing in a Quality Manager to join their growing team. This person will be a "change agent" in the quality space. Why Work Here?...

  • Quality Assurance Manager

    1 month ago

    Itasca, United States Sterling Engineering Full time

    Sterling Engineering is a growing engineering and staffing services firm that specializes in placing top engineering and technical talent into their dream jobs. We have partnered with a leading manufacturer near Schaumburg on bringing in a Quality Manager to join their growing team. This person will be a "change agent" in the quality space. Why Work Here?...

  • Assurance Manager

    4 weeks ago

    Itasca, United States CDH Full time

    Position Summary The Assurance Manager has shared responsibility for the overall operation of the Firm's Assurance department from a staff management, project service and delivery perspective. The Assurance Manager oversees the preparation and delivery of Firm assurance and review engagements. Professional Responsibilities Reports departmental performance to...

  • Assurance Manager

    3 weeks ago

    Itasca, United States CDH, PC Full time

    **Position Summary** The Assurance Manager has shared responsibility for the overall operation of the Firm’s Assurance department from a staff management, project service and delivery perspective. The Assurance Manager oversees the preparation and delivery of Firm assurance and review engagements. **Professional Responsibilities** - Reports departmental...

  • Production Quality Specialist

    7 days ago

    Itasca, United States Systematics Full time

    **Join our team to be part of a high-energy, fast paced, and exciting journey as we create awe-inspiring visual marketing for our clients!** **Summary** The Production Quality Specialist is responsible for creating and implementing quality control and inspection processes throughout the manufacturing stages. This self-motivated individual will check the...

  • Assurance Manager

    2 months ago

    Itasca, United States CDH Full time

    Position Summary The Assurance Manager has shared responsibility for the overall operation of the Firm's Assurance department from a staff management, project service and delivery perspective. The Assurance Manager oversees the preparation and delivery of Firm assurance and review engagements. Professional Responsibilities Reports departmental performance...

  • Assurance Manager

    3 weeks ago

    Itasca, United States CDH Full time

    Position Summary The Assurance Manager has shared responsibility for the overall operation of the Firm's Assurance department from a staff management, project service and delivery perspective. The Assurance Manager oversees the preparation and delivery of Firm assurance and review engagements. Professional Responsibilities Reports departmental performance...

  • Assurance Manager

    3 weeks ago

    Itasca, United States CDH, PC Full time

    Position SummaryThe Assurance Manager has shared responsibility for the overall operation of the Firm’s Assurance department from a staff management, project service and delivery perspective.The Assurance Manager oversees the preparation and delivery of Firm assurance and review engagements. Professional Responsibilities Reports departmental performance...

  • Customs Compliance Specialist

    2 months ago

    Itasca, United States Enesco Full time

    Job DescriptionJob DescriptionDefinition of Enesco's Business:Enesco, LLC is a well-known, recognized international leader in the gifts and home décor industry. Operating under the brand and portfolio trade names of Enesco Gift and Department 56, Enesco is renowned for designing, licensing, producing, and distributing creative, fun, and engaging...

  • Customs Compliance Specialist

    1 month ago

    Itasca, United States Enesco Full time

    Definition of Enesco's Business: Enesco, LLC is a well-known, recognized international leader in the gifts and home dcor industry. Operating under the brand and portfolio trade names of Enesco Gift and Department 56, Enesco is renowned for designing, licensing, producing, and distributing creative, fun, and engaging consumer products. Enesco's portfolio...

  • Customs Compliance Specialist

    3 weeks ago

    Itasca, United States Enesco Full time

    Job DescriptionJob DescriptionDefinition of Enesco's Business:Enesco, LLC is a well-known, recognized international leader in the gifts and home décor industry. Operating under the brand and portfolio trade names of Enesco Gift and Department 56, Enesco is renowned for designing, licensing, producing, and distributing creative, fun, and engaging...