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QC / New Product Development Coordinator

Company: Foamtec International Co.
Location: Woodway
Posted on: November 21, 2022

Job Description:

*Quality Control / New Product Development Coordinator*

*Overview*

QC/NPD Document Control Coordinator has primary responsibility for record-keeping and document management for Foamtec's regulated businesses, including Medical Device, Pharmaceutical, Life Sciences and Microelectronics. The Document Control Coordinator will interface with all levels of sales and operations, both within the US and Thailand, and will follow-up on and report on project status. The qualified candidate will have prior experience with documentation and project management within a life science company that maintains an ISO13585, cGMP quality system.

*Job Responsibilities*

- Maintain files of Finished product specifications, coordinate approvals with sales and customers

- Organize distribution and process procedures to maintain compliance to ISO 90001, ISO 13485, and cGMP

- Provide Certificates of Compliance for custom products, and technical documents such as technical data sheets as requested by Sales Team and customers

- Submit cost and sample requests to counterparts in Thailand, and follow up on project status

- Lead a weekly status meeting with Thailand NPD team and publish notes. Follow up on actions required from Thailand NPD and sales.

- Maintain samples and reports of all new product development

- Interact with regulatory agencies such as US FDA for certification, approvals/certificates, and document from those agencies.

- Review and report that the company is within compliance to ship and store hazardous materials.

- Maintain MRB (Material Review Board) area. Actively work to correct product issues and release products.

- Identify and resolve discrepancies in documentation and labeling.

- Create and control new documentation as needed.

- Prepare internal documentation for submittal to inspectors and auditors from regulatory agencies, customers, and certifying agency auditors.

- Other projects as assigned involving QC and New Product Development

*Knowledge, Skills, and Abilities Required*

- High level of organization skills required

- Ability to work independently in a fast paced, high pressure environment is required

- Advanced knowledge of Microsoft Excel, Word and Outlook

- Advanced communication and problem-solving skills

Job Type: Full-time

Pay: $20.00 - $28.82 per hour

Benefits:
* 401(k)
* Dental insurance
* Health insurance
* Life insurance
* Paid time off
* Tuition reimbursement
* Vision insurance
Schedule:
* 8 hour shift
* Monday to Friday
* Overtime
Supplemental pay types:
* Bonus pay

Ability to commute/relocate:
* Woodway, TX 76712: Reliably commute or planning to relocate before starting work (Required)

Experience:
* Manufacturing: 1 year (Preferred)

Shift availability:
* Day Shift (Preferred)

Work Location: One location%58047475%

Keywords: Foamtec International Co., Waco , QC / New Product Development Coordinator, Other , Woodway, Texas

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