Company Name
Superior Talent Resources, Inc.

Locations
Pune

Experience
10 - 12 years

Key Skills
BE / B.Tech

Function
Manufacturing/ Engineering/ R&D

Role
Software Engineer/ Programmer

Industry
Consultancy

Posted On
13th Jan 2019

Job Ref code
14130

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About Company

With Superior Talent Resources, Inc 's unparalleled agility on your side, there's no telling how far you'll go—in your career search, your workforce management, or your project delivery. But chances are, it'll be farther than you've ever gone before.

Founded in 1957, Superior is a premier provider of workforce solutions and outsourcing around the globe. Trusted by many Fortune 500 companies, our talent acquisition services are nuanced and thorough, and our management solutions provide maximum efficiency via proprietary technology.

Headquartered in the United States, with offices in Argentina, Belgium, Canada, China, Germany, India, Slovakia and the United Kingdom, our company is a proven partner for businesses that believe in setting goals, if only so they can go beyond them.


Quality

Quality is the cornerstone of Superior's business and workplace culture. We have implemented a company-wide quality management system to measure, maintain and continually improve the quality of our service offerings. This system meets ISO 9001:2008 standards and has been certified since 1996 by Bureau Veritas Certification North America, Inc., an internationally accredited registrar.


Our Quality Statement asserts

"It is the policy of the Superior Talent Resources, Inc to provide workforce solutions that meet or exceed our customers' expectations. The defining elements of our policy include the timely placement of well-qualified people, delivery of workforce management, and business solutions, and the provision of services valued by our customers in precise conformance with agreed-upon requirements.

Job Description


Job Description:

1. Creates, develops and executes a comprehensive, risk-based audit plan and schedule, Regulatory Compliance, Quality Management System, and Vendor Quality Risk Management operations.
2. Assures conformance to established quality assurance processes and standards for development, manufacturing and testing of products through review
3. Serve as an independent Quality Assurance (QA) resource on new and custom product development teams as applicable.
4. Support products throughout all phases of product lifecycle from development through on marketsupport.
5. Ensures product documentation complies with internal procedures, external quality standards, and customer requirements.
6. Facilitate product or process improvement projects within product quality or quality system processes. Mentor / Train other employees on quality assurance requirements, processes, and procedures.
7. Understand and comply with ethical, legal and regulatory requirements applicable to our business. Job Requirements:

  • Candidate should have 10-12 years experience, and has great enthusiasm to learn.
  • FDA regulatory compliance, including 510(k) product submissions
  • Design control and process validation
  • Ensures quality products are developed in accordance to governing regulations and processes
  • Understand 21 CFR 820 and ISO 14971 and 60601; ISO 13485 and the EU MDD/ MDR and other domestic and international regulatory standards (i.e. GMP, FDA QSR, ISO, and MDD) in product requirements, design controls, software validation, V&V and operations
  • Actively participate and assist teams with Risk Analysis to include Risk Assessments, DFMEA/PFMEAs, etc.
  • Assists with CAPA investigations and ensures corrections and/or corrective actions for identified non conformances are implemented

Contact:

Srihari M

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