About Goddard: Founded in 1997, Goddard is a dynamic, full-service product development and engineering firm specializing in the design and development of medical technology, life science and industrial products. Drawing from the collective expertise of its experienced designers and engineers, Goddard’s mission is to deliver outstanding solutions that positively impact lives.
Why you should join us:
- Project diversification: Our teams have helped to re-imagine and build products ranging from implantable heart pumps to boat monitors to flying cars.
- On-site partnership model: Our engineers become a part of our clients’ team. Many of our clients opt to host our engineers on-site for the duration of their project. Every Thursday, the entire Goddard staff gathers in our Beverly and San Diego offices to discuss projects. The upshot? No matter where you are, you’re always supported by the whole team.
- We care about culture: From our “dress-for-your-day” policy, Athletic Club and Women’s Network to social hours and summer Fridays, we believe in taking care of our teammates.
Goddard is seeking a Quality Engineer to join our team. The ideal candidate must have a strong track record in medical device or therapeutics quality systems development and maintenance. In this role, you will be responsible for ensuring that activities throughout the product lifecycle follow procedures, standards, and regulations applicable to the products being developed. The Quality Engineer independently develops, applies, and implements methods, tools, and practices to achieve product quality goals and requirements in the areas of design, development, production, distribution, maintenance, and service. This is a technically focused role requiring skills in analyzing information, reviewing technical reports, promoting process improvement, requirements development, risk management, product development and production controls.
About the Role:
- Advise development teams regarding compliance with company QMS procedures, standards, and regulations.
- Participates in the creation, revising, and review of quality documents such as SOP’s, work instructions and templates.
- Participates alongside core teams to support new product development or design changes.
- Ensure successful implementation of Design Controls and Product Realization requirements for design, production, and distribution of products.
- Provides input on product requirements, acceptance criteria, traceability, process monitoring, product evaluation, failure investigation and complaint analysis.
- Ensure product quality meets requirements and documentation is complete prior to approval.
- Ensures application of sound statistical methods and quality tools in the evaluation and documentation of results related to design control, purchased part qualifications, V&V, risk analysis, production transfer, and post-production monitoring.
- Reviews and approves change orders for product performance, process changes, labeling and marketing communications as required.
- Works with R&D, Manufacturing, Service, Business Development, and others outside the company (as needed) to recommend or prepare corrective / preventive actions (CAPA).
- Perform and/or support audits (internal, external, and by regulatory agencies).
- Experience in risk management, and risk assessment techniques, such as FMEA, fault tree analysis, 5 Why's, Fishbone analysis, etc.
- Skilled in statistical methods, gage R&R, statistical process control, sampling plans, and design of experiments.
- Proficiency using the Microsoft Office Suite including Outlook, Excel, Word, PowerPoint, and Visio.
- Bachelor’s degree in science or engineering is preferred.
- 5+ years hands on experience in an FDA QSR and ISO 13485 environment.
- Experience with:
- Working closely with medical device engineers to ensure documentation requirements and standardization.
- All aspects of the product lifecycle, from prototyping to supply chain and production.
- Understanding of ISO 14971 Risk Management requirements and application.
- Developing testing plans and procedures to ensure that products meet clients’ expectations and comply with safety regulations. o Inspecting and testing materials, equipment, and products to ensure specifications are met.
- Self-motivated, and possess strong organizational skills, and outstanding written and verbal communication skills.
- A positive, team-player attitude.
- Able to multi-task, meet tight deadlines, and prioritize changing demands in a fast-paced, entrepreneurial environment.
- High accuracy, thoroughness, and attention to detail in reviewing and completing quality records.
- Demonstrates professionalism during all interactions within company, customer, and third parties.
- Acts with integrity in all situations and can maintain appropriate confidentiality.
Goddard believes that everyone is entitled to fair opportunities and equal employment rights. We comply with all applicable laws prohibiting discrimination in hiring and the terms and conditions of employment including, but not limited to, compensation, promotion, discipline, or termination. Goddard is firm on its policy to provide equal employment opportunity for all employees and applicants on the basis of qualification and merit and will not discriminate on the basis of race, color, creed, religion, national origin, age, disability, genetic information, sex, sexual orientation, gender identity, marital status, veteran status, public assistance status, membership or activity in a local commission, or any other legally protected status in accordance with applicable local, state, and federal laws.