Quality Systems & Documentation Specialist

ProMed Molded Products, Inc.; Plymouth (MN); Híbrido; USD 67 000 - 92 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

401k with company match

Profit Sharing Program

Medical Insurance

Health Savings Account/Flexible Spend

Vision Insurance

Life Insurance

Paid Family Medical Leave and Long‑Ter

Hospital Indemnity, Critical Illness,

Pet Insurance

Resumo da oferta

ProMed Molded Products, Inc. is seeking a Quality Systems Specialist to oversee the document control within the QMS, ensuring accuracy, current revisions, and regulatory compliance across ISO 13485, FDA 21 CFR 820, and 21 CFR Part 11.

You will manage SOPs, forms, and records, coordinate changes and training, and support continuous improvement in manufacturing operations, while maintaining audit readiness and data integrity.

Qualificações

• Bachelor’s degree in Life Sciences, Chemistry, Engineering, or a related field.
• 2-5 years of experience in a regulated industry (pharma, biotech, or medical device).
• Working knowledge of GMP principles, ISO 13485 and FDA regulatory requirements (21 CFR Parts 210/211 and/or 820).
• Proficiency in Microsoft Office Suite (Word, Excel, Outlook).

Responsabilidades

• Administer the day-to-day operations of the document control system, including issuance, revision, approval routing, and archiving of controlled documents.
• Maintain document master lists and revision histories to ensure all controlled documents reflect the current approved version.
• Manage electronic and physical document repositories.
• Process document change requests and support change impact assessments.
• Coordinate training assignments for new and revised documents, ensuring training records are completed and filed.

Conhecimentos

Communication skills

Formação académica

Bachelor’s degree in Life Sciences, Chemistry, Engineering, or a related field

Ferramentas

Microsoft Office

Descrição da oferta de emprego

ProMed Molded Products, Inc. is seeking a Quality Systems Specialist to oversee the document control within the QMS, ensuring accuracy, current revisions, and regulatory compliance across ISO 13485, FDA 21 CFR 820, and 21 CFR Part 11.

You will manage SOPs, forms, and records, coordinate changes and training, and support continuous improvement in manufacturing operations, while maintaining audit readiness and data integrity.