Location: Ambler, PA
Gyroscope: Vision for Life
Gyroscope Therapeutics is building something special – a company to preserve people’s sight and fight the devastating impact of blindness around the world. And if we are successful, our gene therapies and surgical devices will offer people the chance to see what they otherwise would have missed.
To be successful we need the right people. People who have passion for helping patients. People who can work as one toward a common goal, have fun and together bring forward the best ideas. People who celebrate success and embrace failure as an opportunity to learn and grow. If you are one of these people, we would love to meet you.
Quality Assurance Engineer:
The Quality Assurance Engineer develops, coordinates, and implements various activities pertaining to the effective management of the quality management system (QMS) in accordance with 21 CFR Part 820, ISO 13485, customer requirements, and applicable standards.
What we expect the QA Engineer to do:
- Assures medical devices are designed and developed in accordance with 21 CFR Part 820, ISO 13485, and other applicable standards/regulations
- Member of design and development s and performs quality engineering related tasks. Examples of task include:
- Participate in the creation and execution of functional/design requirements
- Support risk management activities including creation of plans, reports, and FMEAs
- Support and approve design verification/validation activities
- Assist in the application of statistical methods
- Participate in design reviews
- Assure cascading of critical to quality features throughout design transfer
- Assures device design is correctly transferred to contract manufacturers
- Audits contract manufacturers and suppliers
- Manages product nonconformance process and is member of Material Review Board (MRB) responsible for the investigation, corrective action, and dispositioning of product nonconformances
- Member of Change Control Board (CCB) responsible for conducting design and documents change impact assessments
- Responsible for customer complaint investigations and recommending corrective actions
- Assures acceptance activities (receiving, in-process, final) are properly defined and executed.
- Compiles data/reports for input to Management Reviews
- Assists VP Quality & Operations in the management of corrective & preventive actions (CAPA) process
- Participates in FDA inspections and ISO 13485 assessments
- Know and follow all laws and policies that apply to one’s job, and maintain the highest levels of integrity, ethics and compliance at all times.
- Additional duties as assigned.
What we would like to see in your skills/experience:
Skills and Knowledge
- Knowledge of applicable regulatory standards such as 21 CFR Part 820 and ISO 13485
- Detail-oriented, self-starter with high attention to detail and ability to work on and coordinate multiple projects/assignments
- Demonstrated ability to organize and manage small to medium-sized projects and effectively participate in cross-functional teams
- Hands-on experience with test equipment including the ability to understand the working mechanisms and methodologies
- Strong written and verbal communication skills
- Strong problem solving and organizational skills
- Intermediate to advanced knowledge of MS Office Suite.
- Requires combination of sitting, walking and standing for prolonged periods of time
- Occasionally uses repetitive movement of (hands, arms, legs)
- Occasionally moves or lifts materials up to 25 lbs. assisted or unassisted
- Vision of 20/20 (corrected or uncorrected) required
- Operates medical device assembly, test, and inspection equipment
- Operates computer equipment, fax/copy machines, telephone, calculator and general office equipment
- Occasional exposure to noisy environment where hearing protection must be worn
- Adhere to QMS requirements outlined in procedures and work instructions
- Ability to work overtime and weekends as needed
- 5 years of experience in a related industry or regulated environment (e.g., ISO 13485, 21 CFR Part 820) in one of the following functions: Quality Control, Manufacturing, and Product Development.
- Associate degree (or higher) related to life sciences or equivalent.
- Minimal travel (possibly one to two times per year for training)
Equal Employment Opportunity
Orbit Biomedical, a Gyroscope Therapeutics company, is committed to Equal Employment Opportunity. It is the policy of the Company to encourage and support equal employment opportunity for all Associates and Applicants without regard to sex, age, race, color, ancestry, religious creed, national origin, pregnancy, physical or mental disability, medical condition, marital status, political affiliation, sexual orientation, disable veteran or Vietnam Era Veteran Status.
Americans with Disabilities Act
Applicants as well as employees who are or become disabled must be able to perform the essential job functions either unaided or with reasonable accommodation. The organization shall determine reasonable accommodation on a case-by-case basis in accordance with applicable law.
The statements contained in the job description reflect the general duties and responsibilities considered necessary to perform the essential functions of the job and should not be considered as a detailed description of all the work requirements of the position. Orbit Biomedical may change the specific job duties with or without prior notice based on the needs of the organization.Apply +