Quality Biological Safety Engineer II
AngioDynamics

Job Info

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JOIN A TEAM COMMITTED TO IMPROVING PATIENT CARE

It takes a team of talented people to become one of the world's leading providers of innovative medical devices.

AngioDynamics is dedicated to improving patient outcomes by focusing on the development of disruptive and differentiated technologies that address unmet patient needs and supporting professional healthcare providers around the world in the delivery of high-quality patient care.

We accomplish this through:

• A Commitment to the Highest Standards of Quality
• Relentless Innovation
• Operational Excellence

Our employees receive the highest level of training and endeavor to be the best and the brightest in the medical device industry.

We are pleased to offer a comprehensive benefit plan that supports the overall health and wellness needs of our employees and their families.

Plans and directs activities concerned with the design, development, application, validation, implementation and maintenance of quality standards to ensure that new and existing products meet requirements for biological safety.

Essential Duties and Responsibilities

• Maintain a comprehensive understanding of global medical device regulations with respect to biological safety, identify and assess emerging standards, theories, and methodologies, and apply gained expertise within the biological safety processes.

• Assess biological safety requirements for new or modified devices or processes.

• Generate protocols outlining required testing, coordinate building and sterilization of test articles, and communicate with laboratory experts.

• Generate reports which document the test results and and provide an interpretation of the compliance of those results with the requirements.

• Maintain a thorough understanding of all product families manufactured.

• Communicate with regulatory agencies to advance product approvals, submission determinations, etc. as it pertains to the biological safety of medical devices.

• Provide support and guidance within the global organization regarding regulatory compliance as it pertains to the biological safety of medical devices.

• Develop and maintain open communication with all internal and external contacts.

• May perform other duties as assigned

Regulatory Responsibilities

• Manages in order to ensure compliance with all relevant regulatory/legal requirements

QUALITY SYSTEMS DUTIES AND RESPONSIBILITIES

Establish and support a work environment of continuous improvement that supports the Quality Policy, Quality System and the appropriate regulations for the area they support. Ensure all employees are trained to do their work and their training is documented

QUALIFICATIONS

• Bachelor Level of Degree in the Engineering field of study

• Equivalent work related experience acceptable in lieu of degree Yes No

• 3 years of demonstrated experience in scientific discipline with an emphasis on chemistry, microbiology, biology, or biomedical sciences.

• N/A Certifications Required

• Any preferred education, experience or certifications: 3 years of medical device experience preferred

Skills/Knowledge

• Familiarity with regulations and standards published by FDA, USP, HIMA, AAMI, ANSI, ASTM, and ISO.

• Knowledge of probability and statistics, experimental design methods.

• Technical writing and oral communication skills.

• Working knowledge of computers, spreadsheets, databases, and statistical programs.

• Proficient in the following computer software applications: Microsoft Office

• Exceptional interpersonal skills.

• Strong organizational skills.

• Strong communication skills (written and verbal).

• Ability to effectively communicate both internally and externally.

• Ability to read and interpret documents such as safety rules, operating and maintenance, instructions, and procedure manuals. Ability to write routine reports and correspondence.

PHYSICAL/WORK REQUIREMENTS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job:

• Work safely and follow all OSHA regulations and company safety policies and procedures.

• For all on-the-job injuries or accidents, must notify manager/supervisor immediately.

• Exposure to (insert any extreme climate and/or work conditions) standard office environment

• Ability to frequently lift and/or move up to 15 (insert # lbs.)

• Ability to occasionally lift and/or move up to 50 (insert # lbs.)

• Ability to regularly sit or stand for extended periods of time (insert physical abilities, repetitive movement, vision requirements, etc.)

• This position requires some travel up to 10% of the time

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other legally protected status.

The Company will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.

AngioDynamics does not accept resumes or candidate submissions from third-party recruiters and/or vendors who are not expressly under current written contract.

This job has expired.