Apex Systems is seeking an Engineer II for our client in the medical device industry. This position will be working on product quality, including verification and validation for new product designs.
For immediate consideration, please email your resume directly to Jenny DeMaria at [ Email removed ] - URL blocked - click to apply!
Responsible for providing Quality support and oversight via process/area responsibilities. Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and company quality practices. Support development and integration of disposables into electromechanical systems.
Top 3 must haves:
- Product Quality experience with Infusion Pump systems – Disposables and interface experience preferred
- Verification and validation experience
- NPD quality experience.
Top Technical skills needed:
- Requirements development and review
- Test Case development and review
Essential Duties and Responsibilities:
- Perform in depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude.
- Assessments and information gathering may be through in depth employee interviews, flow charting and other informational gathering techniques.
- Determine the logic, adequacy and effectiveness of processes, systems and related requirements.
- Develop plans to correct identified risks including areas of non-conformance, inform management and implement approved corrective action plans.
- Write, review, analyze and revise product documentation including test protocols, reports, test cases, studies, requirements, and risk documentation as needed.
- Collaborate with cross functional team to support project objectives and ensure compliance to internal and external requirements.
- Support design and technical reviews through data gathering and analysis
- Support development and structuring of DHF elements
- Support external assessments or audits.
- Strong interpersonal skills and great attention to detail are necessary.
- Must be able to handle multiple projects concurrently.
- Have strong knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
- Must be a strong team player with good problem solving and good verbal and written communication skills.
Education and/or Experience:
- Bachelor’s degree in the life sciences (or engineering) and experience with a medical device/pharma or other similarly regulated industry required
- Experience with electromechnical systems design
- Experience with disposables set design and integration
- Experience with DOORs and HP ALM preferred.
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [ Phone number blocked ] - ||
Attention To Detail
Complex Problem Solving