Job Description
Job Title: Senior Quality Specialist – External Manufacturing and Supplier Management
Location: Parsippany, NJ
Duration: 12 months contract
Description :
About the role:
This Senior Quality Specialist will be responsible for ensuring that NA products manufactured at third party contract sites comply with all the applicable regulations as well as with our corporate quality standards during their whole life cycle. This professional will interface with several areas and will work closely with the Supply teams providing guidance on the quality requirements for the qualification and maintenance of new, existing external manufacturers and suppliers. The role would support continuous improvement efforts at existing manufacturing sites.
Key Responsibilities
Location: Parsippany, NJ
Duration: 12 months contract
Description :
About the role:
This Senior Quality Specialist will be responsible for ensuring that NA products manufactured at third party contract sites comply with all the applicable regulations as well as with our corporate quality standards during their whole life cycle. This professional will interface with several areas and will work closely with the Supply teams providing guidance on the quality requirements for the qualification and maintenance of new, existing external manufacturers and suppliers. The role would support continuous improvement efforts at existing manufacturing sites.
Key Responsibilities
- Provide quality lead for all external manufacturing related activities and suppliers, the resolution of investigations, questions or complaints, and ensuring end-to-end success of projects and products.
- Partner with the Supply teams in assuring that the stages of the development process comply with all our Quality corporate requirements.
- Analyze and prepare Quality documentation for the launch of new products and for the change of the existing ones, such as technical manuals, technical agreements and good for sale certificates.
- Perform Quality risk assessments for new and existing external manufacturing operations.
- Act as Quality representative during trials and validation activities at external manufacturers.
- Lead the scheduling, execution, reporting and tracking of onsite audits of external manufacturers and suppliers to confirm that these operations are performed in compliance with EH's Global QMS and meet all relevant regulatory requirements.
- Maintain quality system processes and establish a supplier qualification program (such as Change Control, Supplier Management, Deviations and Investigations, CAPA, and others as needed).
- Track audit findings for suppliers to completion and ensure timely closure of audit reports and ensure adequate CAPAs are developed by external manufacturers, suppliers and monitor their closures.
- Analyze errors and deviation from process and procedures, hold key stakeholders accountable, and provide guidance on key actions and steps required to correct deviations.
- Interfaces with Supply and Procurement leadership for escalation of quality issues.
Qualifications
- Minimum of a BA or BS degree, preferably in engineering, life, or natural sciences.
- 10+ years' experience in Quality Assurance / Quality Control Systems in a regulated environment.
- Must be quality-focused and detail-oriented.
- Must possess a high level of strategic mindset, proactive ownership, initiative and adaptability necessary for a fast-paced and founder driven environment.
- Must possess the competence to perform tasks requiring analytical and problem-solving skills.
- Must demonstrate outstanding teamwork in interacting with other team members.
- Excellent written and verbal communication skills, problem-solving, decision-making skills, and computer proficiency.
- Experienced in Good Manufacturing Practices.
- Experienced in quality systems, such as ISO 9000, GMP, HACCP, and Auditing.
- Experience conducting audits including planning and follow-up on CAPAs resulting from the findings.
- Travel required (approx. 20-30%), intermittent and planned, localized to Midwest and East Coast, and may likely go down over time.
Compensation:
The hourly rate for this position is between $35.00-45.00per hour.
Factors which may affect starting pay within this range may include [geography/market, skills, education, experience and other qualifications of the successful candidate].
Benefits:
Sunrise offers ACA compliant medical coverage/dental insurance/vision insurance to all employees. We also offer Sick time benefits as required per State regulations.
Contact:
Jaya Balaji: jayabalaji.s@sunrisesys.com | (732) 515-5373 | URL: www.sunrisesys.com
Numbers & Facts
| Location | Parsippany, NJ |
| Industry | Staffing/Employment Agencies |
| Salary | $35–$45 Per Hour |
| Company Size | 100 to 499 employees |
| Year Founded | 1990 |
| Website | http://www.sunrisesys.com/ |
About Company
Sunrise Systems was founded in 1990 with a clear vision to deliver world-class staffing service solutions in all labor categories, including IT consulting and solutions; all with the commitment to provide service that exceeds expectations and become the most trusted name in the industry. More than two and a half decades later, we pride ourselves on being at the forefront of the staffing industry. Combining our deep industry expertise, insights, and global resources, we have partnered with our clients to connect them with top professionals across several different industries.
We provide cost-effective Managed Staffing Solutions, Information Technology and Information Technology Consulting Services to several Fortune 500 companies and U.S. Government agencies. We provide our clients with flexible engagement models and customized products that are budget and time specific. Understanding the challenges that every business faces, we offer our services either on-site at the clients' site or from one of our globally distributed technology centers. Our onshore and offshore development capabilities ensure that we excel at meeting customer requirements every single time.
Our collective business experience spans over two and a half decades and ranges from:
- Business, management, and technical fields
- Information technology consulting and software solutions.
- Providing strategic support for the development and long-term growth of new business ventures across several industries including but not limited to; accounting, banking, finance, and recruitment.
- Motivating technology staff and establishing partnerships with Fortune 500 companies
Sunrise Systems has a vast range of competence in:
- Design, development, and support of cloud-based solutions from simple to highly complexed
- Database administration of multi-platform applications, complex databases, and web-based environments that include all aspects of installation, planning, maintenance, and monitoring.
- Data processing and data migration
- Application re-engineering and platform migration
- Working with the Information Systems and end-user communities at all levels to resolve issues and establish consensus.
Skills
- Analysis Skillsunmatched
- Auditingunmatched
- Change Controlunmatched
- Communication Skillsunmatched
- Computer Skillsunmatched
- Continuous Improvementunmatched
- Control Systemsunmatched
- Corrective and Preventative Action (CAPA) Systemsunmatched
- Detail Orientedunmatched
- Documentationunmatched
- External Auditunmatched
- GMP (Good Manufacturing Practices)unmatched
- ISO 9000unmatched
- Leadershipunmatched
- Manufacturingunmatched
- Manufacturing Managementunmatched
- Manufacturing Operationsunmatched
- Natural Scienceunmatched
- People Managementunmatched
- Presentation/Verbal Skillsunmatched
- Problem Solving Skillsunmatched
- Product/Service Launchunmatched
- Purchasing/Procurementunmatched
- Quality Assuranceunmatched
- Quality Controlunmatched
- Quality Managementunmatched
- Quality Metricsunmatched
- Regulationsunmatched
- Regulatory Requirementsunmatched
- Risk Analysisunmatched
- Salesunmatched
- State Laws and Regulationsunmatched
- Systems Maintenanceunmatched
- Team Playerunmatched
- Technical Writingunmatched
- Time Managementunmatched
- Vendor/Supplier Evaluationunmatched
- Vendor/Supplier Managementunmatched
- Vendor/Supplier Selectionunmatched
- Willing to Travelunmatched
- Writing Skillsunmatched
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