The Quality Technician will provide QA/QC technical and compliance expertise as part of teams tasked with establishing and assuring system and product quality objectives.
The Quality Technician will assure compliance to applicable regulations and J&J Quality Standards and perform quality activities such as data analysis, QMS audits, procedure development, product release, documentation review and implementation of changes to controlled documents
Duties and Responsibilities:
Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate, procedures and guidelines, this position:
- Provides QA technical and compliance support for products and manufacturing related to suppliers, corrective and preventive actions, product/process improvements and training.
- Monitors compliance of policies, procedures and applicable regulatory requirements, identifying and implementing process and system improvements as applicable.
- Applies thorough, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Plans, executes, reports and follows-up on quality system audits (internal)
- Actively participates in and supports departmental activities and responsibilities in accordance with existing procedures and external regulations.
- Makes decisions that are aligned with management objectives regarding work processes, plans and schedules to achieve quality objectives.
- Tracks and reports progress across projects and departmental commitments by reviewing schedules and due dates, identifying risks, and assisting teams with contingency plans.
- Resolves project issues by working with team members, management, suppliers, and others as appropriate.
- Assists department and project leaders in developing and reporting appropriate performance and quality metrics.
- Reviews and approves manufacturing, test and validation data/records to establish conformance to technical specifications and performance standards for existing, new or modified products and processes.
- Responsible for communicating business related issues or opportunities to next management level
- Support and facilitate the administration of the Windchill documentation management system and overall change control process.
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
- Performs other duties assigned as needed.
· 1 year minimum experience in the medical industry, experience in QA, Quality System or regulatory a preferred.
· Qualification in Engineering, Science or related technical field preferred.
· Knowledge of the preparation for notified body and FDA inspections advantageous.
· Knowledge of the QA activities associated with a manufacturing environment.
· Proficient in basic IT skills relevant to the applications related to the tasks assigned, i.e. the use of word processors and similar windows-based applications, e.g. MS Office products.
· Ability to achieving results
within assigned deadlines with an ability to handle multiple tasks and operate in a fast-paced environment.
· Ability to work cooperatively with coworkers and the public.
· Ability to perform duties in accordance with policies and procedures and to comply with civil rights requirements.
· Demonstrates an ability to apply, recommend and/or create quality tools and apply them effectively to a variety of business situations related to production, project and team environments.
· Knowledge of FDA’s 21 CFR Part 820 (Quality System Regulation), ISO 13485:2016, the European Medical Device Directive/Regulation. Knowledge of other applicable medical device regulations, e.g. Brazilian, Canadian, Australian, Japanese, Korean, etc., advantageous.
· Good interpersonal skills and ability to work with people to achieve results.
· Good written and communication skills, fluency in English.
· Good judgment/decision making and problem-solving ability, capable of understanding the impact of decision making on both our client and their customers.
· Motivated and an enthusiastic self-starter with the ability to work under own initiative and as a team player.