RESPONSIBILITIES:
Kforce has a client in need of a Quality Systems Engineer in Andover, MA.
Responsibilities:
* Supports the overall QMS processes for the organization. Responsible for activities required to ensure compliance of Quality Management Systems (QMS), specifically regarding CAPA and internal/external audits; Additional responsibilities include supporting other QMS functions such as NCMRs, Supplier Controls, Management Review, Risk Review, etc.
* Execution and coordination of activities associated with CAPA program, including administration and record management, providing quality input to investigations, reporting, as well as metrics and trending
* Support CAPA Owners in quality-related technical principles, including but not limited to Problem Solving tools and techniques (Root Cause Analysis, DOE, FMEA, etc.)
* Manages the Internal Audit program, including scheduling audits, ensuring timely response to findings, as well as metrics and trending
* Support external audits and inspections by providing subject matter expertise
* Development of Quality Metrics, and coordination of quality data collection and analyses for use in monthly metrics meetings and Management Reviews
* Provide quality assurance support cross-functionally across the organization
* Lead/participate in Risk Management and FMEA initiatives
* Develop, implement, and manage Quality Control/Quality System process improvements
* Identify opportunities for improvement within the Quality System to ensure compliance and efficiency. Correct or improve gaps/opportunities in an independent fashion by writing and releasing new or revised Quality System documentation
* Understand how and when to escalate quality issues to leadership team within the organization, presenting data and information necessary to draw conclusions and take action
* Provide training and support to employees on quality processes and procedures
* Support work on quality plans, quality processes and special projects, as required
REQUIREMENTS:
* Bachelor's degree in Engineering, Biomedical Science, or other technical discipline preferred, with 5-7 years of relevant experience in medical device industry, including responsibility for Product Quality and/or Quality Systems
* A working knowledge of Quality System Standards and regulations, including 21 CFR Part 820, ISO 13485, EU MDR
* Ability to multi-task, handling multiple projects and changing priorities
* Experience in the creation and documentation of procedures and processes
* Proficiency with Microsoft Office - Word, Excel, PowerPoint and Access experience required
The pay range is the lowest to highest compensation we reasonably in good faith believe we would pay at posting for this role. We may ultimately pay more or less than this range. Employee pay is based on factors like relevant education, qualifications, certifications, experience, skills, seniority, location, performance, union contract and business needs. This range may be modified in the future.
We offer comprehensive benefits including medical/dental/vision insurance, HSA, FSA, 401(k), and life, disability & ADD insurance to eligible employees. Salaried personnel receive paid time off. Hourly employees are not eligible for paid time off unless required by law. Hourly employees on a Service Contract Act project are eligible for paid sick leave.
Note: Pay is not considered compensation until it is earned, vested and determinable. The amount and availability of any compensation remains in Kforce's sole discretion unless and until paid and may be modified in its discretion consistent with the law.
This job is not eligible for bonuses, incentives or commissions.
Kforce is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.
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Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
- Dice Id: kforcecx
- Position Id: ITAQG2159596
- Posted 3 days ago
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