Position Summary
Responsible for facilitating the development, implementation and monitoring of quality programs, plans, SOPs and policies that ensure the development and maintenance of a Quality System in compliance with corporate policies, FDA regulations, ISO 9001, ISO 13485:2003, and other regulatory requirements as applicable.
Responsibilities
90% for the following activities:
1. Assist in design, development and maintenance of a Quality System compliant with cGMPs and ISO and other International regulations.
2. Participate in department meetings to provide input into the design and implementation of product quality planning systems and procedures.
3. Write, review and edit documents and SOPs as required.
4. Coordinate FDA inspections, ISO Certification and surveillance audits and customer and supplier audits.
5. Coordinate development of responses to external audits.
6. Track observations, responses and action items resulting from external audits.
7. Follow-up on corrective action responses, ensuring implementation of appropriate problem resolution methods and verifying effectiveness.
8. Interface to other departments on continuous improvement of the Quality System.
9. Facilitates problems solving activity through TQM, team building and quality systems tools and methods. Works with the line and process supervisors in identifying negative quality trends and repetitive defects.
10% for the following activities as requested
1. Perform special projects on request.
2. Carry out other duties as required or assigned
Requirements
BS or MS degree in technical/scientific/engineering discipline, with at least 7 years of experience in medical devices, in vitro diagnostics, pharmaceuticals or a related industry. Experience working with the FDA and/or ISO auditors’ required ASQ certification (CQE, CRE, and CQA) is preferred. Ability to coordinate multiple projects and excellent working knowledge and experience of FDA's Quality System requirements (QSR), ISO 9001 and ISO13485:2003 standard. QA experience in software is a plus.
The candidate should have strong analytical, communication and interpersonal skills. Strong linguistic, grammar, and editing skills. Ability to multi-task in an environment with changing priorities.
Proficiency with Microsoft applications Word, Excel, Project, and PowerPoint. And ability to learn additional software applications, as the need arises.
Ø Medical PPO / Dental / Prescription / Vision Plans
Ø Health and Dependent Care Flexible Spending Accounts
Ø 401(k) Plan with Company Matching Contributions
Ø Short and Long Term Disability Insurance
Ø Paid Vacation Leave, Sick Leave, Holidays
Ø Extended Holiday Break
Ø Contribution to Fitness Club Membership
It is the policy and practice of the Company to offer equal employment opportunities to all qualified applicants and employees without regard to race, color, age, religion, national origin, sex, political affiliation, sexual orientation, marital status, disability, veteran status, genetics, or any other protected characteristic.
This policy applies to all areas of employment, including recruitment, hiring, training and development, promotion, transfer, termination, layoffs, compensation, benefits and all other terms, conditions and privileges of employment.
