Quality Control -New Product Development Coordinator

Provide Certificates of Compliance for custom products and technical documents, such as technical data sheets, as requested by the Sales Team and customers. The Quality Control / New Product Development Coordinator is responsible for record-keeping and document management for regulated businesses, including Medical Device, Pharmaceutical, Life Sciences, and Microelectronics.

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Overview

The Quality Control / New Product Development Coordinator is responsible for record-keeping and document management for regulated businesses, including Medical Device, Pharmaceutical, Life Sciences, and Microelectronics. This role involves interfacing with all levels of sales and operations in the US and Thailand, and reporting on project status. The ideal candidate will have experience in documentation and project management within a life science company that maintains an ISO13585, cGMP quality system.

Job Responsibilities

• Maintain files of finished product specifications and coordinate approvals with sales and customers.
• Organize distribution and process procedures to maintain compliance with ISO 90001, ISO 13485, and cGMP standards.
• Provide Certificates of Compliance for custom products and technical documents, such as technical data sheets, as requested by the 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 the Thailand NPD team, publish notes, and follow up on required actions from the Thailand NPD and sales teams.
• Maintain samples and reports of all new product development.
• Interact with regulatory agencies such as the US FDA for certifications, approvals, and documentations.
• Ensure compliance in shipping and storing hazardous materials.
• Maintain the Material Review Board (MRB) area and 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 submission to inspectors and auditors from regulatory agencies, customers, and certifying agency auditors.
• Participate in other projects involving QC and New Product Development as assigned.

Knowledge, Skills, and Abilities Required

• High level of organizational skills.
• Ability to work independently in a fast-paced, high-pressure environment.
• Advanced knowledge of Microsoft Excel, Word, and Outlook.
• Strong communication and problem-solving skills.

Qualifications

• 4-year college degree in science or equivalent.
• 5 years of experience in regulatory and/or product development/product manufacturing.

 

Benefits PEAK's benefit offerings available for our associates include medical, dental, vision, Flexible Spending Account (FSA), Dependent Care Savings Account (DCA), and 401K plan.PEAK believes that taking care of our team is essential for success and we are proud to provide benefits that enhance both your well-being and your future. Additionally, our associates may be eligible for Paid Sick Leave as required by Federal, State, or local laws. Equal Opportunity Employer (EEO) PEAK Technical Staffing is committed to creating a diverse and inclusive environment and is proud to be an Equal Opportunity Employer. PEAK does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status, or any other characteristic protected by applicable law. All employment decisions are made based on qualifications, merit, and business need. We encourage all individuals to apply. Americans Disabilities Act (ADA) The physical and mental requirements described in this job description are representative of those that must be met by an employee to successfully perform the essential functions of the position. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.Must be able to perform the essential physical functions of the position, including sitting, standing, walking, stooping, kneeling, andlifting upto 25 pounds, with or without reasonable accommodation. Candidate Privacy To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://peaktechnical.com/privacy-policy/and https://peaktechnical.com/ca-residents-privacy-rights/ AI Recruiting Disclosure We use AI-assisted tools to help review applications and compare your experience to job requirements, but all hiring decisions are made by human recruiters. You may request a human-only process or opt out of automated communication at any time. Required notices and our latest bias audit are available on our website: www.peaktechnical.com/ai-disclosure.