Manager:

Skills/ Experience/ Background:

Minimum bachelor's degree in science/engineering or equivalent experience.
5+ years of relevant experience.
MDSAP certification is mandatory for this role- training will be provided.
Candidate should have working knowledge of design control.
Knowledge of FDA and IVDR regulations is required.
Medical device experience is required.
Experience with design documentation review and investigation tools is helpful.
Candidates with 15+ years of experience are acceptable; they will not be overqualified.

Project Focus:

Primary focus: Extend the existing

BARRICOR

product into the US market.

Additional support on other sustaining projects may be needed depending on the regulatory strategy.
Data analysis, statistical analysis, and root cause investigations during testing.
Work closely with cross-functional teams including R D, Medical Affairs, Regulatory, and Manufacturing (UK sites).

Requirements Will handle projects and tasks from inception through launch and Maintenance 5 + years of experience BS Degree FDA , Med Device, required Able to present to upper management Design control, Risk, Supplier Qualifications, Input, Output, FMEA's and DOE's, SPC's, Validation Job Description The Quality Engineer is accountable for supporting new product development and product maintenance through the application of Quality Engineering skills for medical devices. This person will handle projects and tasks, from product inception through product launch and maintenance, and play an active role in the process to ensure products meet quality standards consistent with both Corporate and Unit policies, while meeting all design control and other regulatory requirements.

Job Responsibilities:

(Primary Duties, Roles, and/or Authorities) Consistent application of technical principles, theories, concepts, techniques, and quality sciences/tools. Proven problem-solving skills. Makes measurable improvements to client processes and procedures. Ensures that all design control and production/process control projects meet applicable regulatory (local and international), Corporate, and Unit requirements. Acts as a team member representing Quality on new product development and sustaining engineering projects. Reviews and has Quality Engineering approval authority for new and modified design/process specifications including product performance specification, test methods, etc. Assists with supplier and internal quality system audits as a means of evaluating the effectiveness of the established Quality System and good manufacturing practices (Auditor-in-training). May perform other duties as required.

Education and Experience:

Typically requires a minimum of a bachelor's degree in science, engineering, or other relevant discipline and a minimum of 5 years relevant experience or a combination of equivalent education and relevant experience.

Knowledge and Skills:

Applied knowledge of the FDA medical device quality system regulations and international quality system standards/regulations (e.g. - 21 CFR Part 820, ISO 13485, ISO 14971, MDSAP, EU

MDR/IVDR

) as it relates to the design and continued support of client products. Applied knowledge of Corporate and/or Unit requirement. Able to contribute to the completion of specific programs and projects. Can ensure quality conduct of projects, including design, data summary and interpretation, and report generation for self and lower level project developers. Able to revise policies and procedures Able to make presentations Can independently determine and develop approach to solutions. Able to provide guidance and work direction to lower level project developers. Can design and perform development working independently within defined parameters with minimal supervision required. 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