Jobs

Description

1st shift: 8am-5pm

100% onsite

Job Summary:

• Designs, implements and maintains quality assurance protocols and methods for processing materials into partially finished or finished products.
• Responsible for planning, implementing and managing compliance of manufacturing and production processes with internal and external safety, quality and regulatory standards requirements for worldwide distribution.
• Designs methods and procedures for inspecting, testing and evaluating the precision and accuracy of production processes, production equipment and finished products.
• May ensure compliance to in-house and/or external specifications and standards (i.e. GLP, GMP, ISO, Six Sigma).

Essential Duties and Responsibilities:

• The incumbent may be asked to perform other function-related activities in addition to the below-mentioned responsibilities as reasonably required by business needs.
• Write & Execute TMV's and Simple Change Orders (Simple Procedure updates, no validations required, clarifications, etc)
• Support Moderate to Complex Project Change Orders (validations, risk analysis updates, creation or major changes of SOP's/documents, etc)
• Write & Execute PQ's
• Lead/Own CAPA's
• Support HRA's/HHE's
• Model all quality values and coaches others on BSH quality system requirements and standards to elevate team's ability to produce high-quality products and implement best practices that emphasize defect prevention, reduction in variation and waste and provide for continuous improvement.
• Provide quality engineering support to Operations, Engineering and R&D in the design and manufacture of medical devices to ensure robust product builds and the production of high-quality products and manufacturing practices.
• Investigates and processes Quality System Investigations (QSI) and Non-Conforming Events (NCE).
• Prepares reports assessing the suitability and effectiveness of assigned areas of the quality system.
• Active participation in processes and meetings such as MRB, NCE, CAPA and SCAR process.

Qualifications:

Education

• Preferred Minimum Technical/Advanced Degree: Technical Bachelor’s Degree

Skills

• Excellent computer skills including ability to use word processing, spreadsheet programs and databases
• Good presentation skills
• Good interpersonal skills to interact with all levels of the company, sometimes in an adversary role
• Knowledge of GMP and GDP Principles
• Working knowledge of medical device Quality System Regulations (21CFR820), ISO 13485 and MDD requirements is beneficial.

Physical Demands:

The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• ??? Sit; use hands to finger, handle or feel objects, tools, or controls.
• ??? Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.
• ??? Lifting/moving and carrying products weighing up to 40 pounds.
• ??? Exposure to moving mechanical parts, vibration and/or moderate noise levels.
• ??? Exposure to hazardous chemicals or other materials.
• ??? Safety Shoes with Impact and Compression Protection Must be worn in designated areas.
• ?? Exposure to blood.