COMPANY
OriGen Biomedical, Inc., is a global leader in cryopreservation and cell culture. We collaborate with top researchers, clinicians, and business partners to enhance solutions, improve patient outcomes, and achieve customer satisfaction by providing safe and effective products that positively impact the quality of life.
POSITION SUMMARY
The Quality Engineer I is responsible for technical duties within the Quality organization including validation and qualification, calibration, and customer contact. These duties will support manufacturing operations, customer service, process improvement, and Regulatory requirements.
ESSENTIAL DUTIES AND RESPONSIBILITIES
The essential duties and responsibilities of this position include, but are not limited to the following:
- Plan and coordinate microbiological programs within the Quality department, including:
- Bioburden monitoring per ISO 11737-1
- Pyrogen monitoring per USP<161> and <85>
- Cleanroom qualification ISO 14644
- Consult on microbiological aspects of sterilization qualification, including:
- Gamma per ISO 11137
- Ethylene Oxide per ISO 11135
- Perform routine complaint investigations and draft summary reports to customers.
- Develop Root Cause Analysis on problems originating from many sources, from production to end-user, including ownership of CAPAs and Nonconformance reports (NCR).
- Technical writing to include standard operating procedure (SOP) document, test protocols, and test reports, investigational summaries, risk assessment, and assistance with regulatory submissions.
- Support with process and design verification and validation activities.
- Execute risk assessment per ISO 14971 including risk planning, data collection, prediction of hazards and hazardous situations, and reporting.
Other duties and/or projects as assigned.
REQUIRED SKILLSETS
- Must be detail-oriented
- Must be proficient on a computer, possessing basic navigation and program knowledge
- Must be able to absorb, assimilate and accurately recall/locate and retain large quantities of data/information
- Must be able to read, write, speak and fully understand English
COMPETENCIES
- Self-starter
- Good math, technical writing and computer skills
- Close attention to detail
- DOE and validation testing
- Familiar with quality tools and procedures
- Broad creativity and curiosity
- Organizational and time management skills
- Seasoned problem-solving skills
- Ethical Conduct
- Communication and interpersonal skills
- Can work with changing priorities
- Adaptability
- Results-driven
- Decision making
MINIMUM QUALIFICATIONS (KNOWLEDGE, SKILLS, & ABILITIES)
- Bachelor's degree in Engineering or 1 – 2 years’ experience in medical device quality / ISO 13485
- Demonstrated ability to use effective and results-oriented problem solving and critical thinking skills; hands-on troubleshooting ability
- Ability to understand and interpret customer needs; ability to work with all work functions (i.e. Regulatory, Operations, Human Resources, Engineering)
- Ability to work independently and lead or participate in a team environment
PREFERRED QUALIFICATIONS
- 3-5 years’ experience in medical device quality / ISO 13485
- 2+ years' experience in a manufacturing environment Knowledge of Lean concepts
SUPERVISORY RESPONSIBILITY
This position has no supervisory responsibilities. This position may be required to lead/report on projects and ensure participants meet deadlines.
WORK ENVIRONMENT
This job operates in a climate-controlled warehouse and/or professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines. The noise level in the work environment is generally moderate however periods of higher-level noise may occur.
This job may also operate in a cleanroom environment. The cleanroom environment requires personnel to wear personal clothing completely covering the legs; company-provided cleanroom attire; e.g. coat, bouffant, face mask, and gloves.
Must be able to stand or sit for extended periods. Must be able to wear personal protective equipment when required
PHYSICAL DEMANDS & WORK ENVIRONMENT
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential job duties and responsibilities of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.
While performing the duties of this position, the employee is regularly required to talk and hear. The employee is frequently required to use hands, fingers, handle or feel objects, tools, or controls. The employee is frequently required to stand, walk, climb, sit, stoop, bend, and reach with hands and arms. The employee must frequently lift and/or move up to 50 pounds and may be required to operate automated warehouse equipment; e.g. electric pallet jack, or forklift. Specific vision abilities required by this position include close vision, distance vision, color vision, and the ability to adjust focus.
NOTE
This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. All duties and responsibilities are essential functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbents will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities. This document does not create an employment contract, implied or otherwise, other than an “at-will” relationship