Quality Biological Safety Engineer II - Career Portal in Marlborough, MA at Angiodynamics, Inc.

Date Posted: 5/5/2022

Job Snapshot

Job Description

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.

Supports plant environmental systems and product monitoring programs.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.
  • Serve as QA representative in matters of environmental monitoring, including controlled area design, change, and monitoring.
  • 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

Supervisory Responsibilities No

Regulatory Responsibilities

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

QUALITY SYSTEMS DUTIES AND RESPONSIBILITIES

Management

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–The requirements listed below are representative of the knowledge, skill or ability required.

Education and Experience

  • Bachelor's: Engineering field of study
  • Equivalent work related experience acceptable in lieu of degree: No
  • years of demonstrated experience in 3scientific discipline with an emphasis on chemistry, microbiology, biology, or biomedical sciences.
  • No Certifications Required
  • 2 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 standard office environment
  • lbs. frequently 15
  • lbs. occasionally50
  • sit or stand for extended periods of time
  • 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.

Other details

  • Job Family :2.1 Technical Professionals
  • Job Function :Quality
  • Pay Type :Salary