Quality Assurance Specialist II

Technipaq, Inc; Crystal Lake (IL); In loco; USD 50.000 - 80.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical insurance

Dental insurance

Vision insurance

Paid sick time

Paid vacation time

401(k) with company match

Paid holidays

Descrizione del lavoro

Technipaq, Inc. is seeking a Quality Specialist II to join the Quality team to support the health and compliance of the QMS in line with ISO 13485.

The role focuses on maintaining the QMS, including document and record control, change management, and training processes, with responsibilities for electronic QMS systems under the Quality Director. The position requires 2–4 years of QA administrative support in ISO manufacturing, with preferred Associate or bachelor's degree.

Competenze

• 2–4 years' administrative support within a QA capacity in an ISO-certified manufacturing environment.
• Associate or bachelor's degree preferred.
• Must be at least 18 years old and pass pre-employment tests.

Mansioni

• Maintain and support the Quality Management System (QMS) in alignment with ISO 13485.
• Support document and record control, change management, and training processes.
• Administer electronic systems for QMS management and maintenance.

Conoscenze

Strong organizational skills

Communication skills

Formazione

Associate or bachelor's degree preferred

Strumenti

MS Office (Word, Excel)

Descrizione del lavoro

Technipaq is family owned and operated serving the medical device and pharmaceutical packaging industry since 1984. We started as a small one machine company and now operate over 160,000 square feet of manufacturing space with 3 manufacturing and warehouse facilities and 180+ employees. Our manufacturing facilities perform the laminating, slitting, sheeting, die cutting, fabricating, and flexographic printing of pouches, lids and roll stock produced in a variety of sizes from foil, film, Tyvek and paper laminates. We offer employees a full benefits package including medical, dental, vision, paid Sick and Vacation time, 401(k) with a company match, and paid holidays.

The Quality Specialist II's overall purpose is to work as a member of the Quality team to support the overall health and compliance of the Quality Management System in alignment with ISO 13485 regulations. This role will have a heavy focus on the maintenance of the quality management system (QMS), with direct support and/or ownership of the document and record control, change management, and training processes. The Quality Specialist II will be responsible for supporting the administration and maintenance of electronic systems implemented for the management and maintenance of the QMS. The Quality Specialist II works under general supervision of the Quality Director.

Requirements

• 2 - 4 years previous administrative support within a QA capacity in an ISO certified manufacturing environment required.
• Associate or bachelor's degree preferred.
• Must be at least 18 years of age and pass our pre-employment Reading and Ruler tests.
• Previous experience leading and participating in customer and supplier audits in an ISO 13485 environment preferred
• Proficient in MS Office including Word and Excel required.
• Previous experience performing internal audits preferred
• Working knowledge of calibration systems and/or ISO Internal Audit experience preferred.
• Strong organizational skills and the ability to effectively communicate and share knowledge with others is also required.

Shift available:

• 8:00 am to 4:30 pm M-F

NO PHONE CALLS PLEASE!! We will contact applicants for an interview if interested. Thank you.