Senior Specialist II, Quality Engineer
A career at Resilience is more than just a job – it’s an opportunity to change the future.
Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.
For more information, please visit www.resilience.com
Position Summary & Responsibilities:
This position will be part of the Quality Control team where they will be responsible for contributing to the on-time development of incoming component testing strategy and will be responsible for subsequent improvements for incoming inspection of materials and optimization of processes as needed. This position will also be responsible for tracking and trending of QC release and stability data. Provide support in statistical analysis of analytical data to support method lifecycle management. Support periodical review of laboratory investigations and invalid investigations.
On time quality delivery of assigned component and material deliverables
Optimize existing processes to maximize efficiencies and continue to identify, plan, and execute continuous improvement activities
Drive continuous improvements through observation, measurement, and root cause analysis
Develop new processes which support agility and quality improvements
Provide subject matter expertise for assigned processes to users as necessary
Responsible for cross functional collaboration with MS&T, Quality and Manufacturing
Provide coaching respective to investigative methods, risk mitigation techniques, DOE, statistical analysis, Reliability, and other related techniques (including Six Sigma, FTA, FMEA, HALT, etc.)
Provides investigative support/leadership for product quality issues and serve as technical resource for investigations to guide root cause analysis and corrective action development
Lead and facilitate Practical problem solving, Level Zeros and HPELs
Disposition, perform containment, and evaluate the risk of nonconforming material
Identify root cause and corrective action by supporting the CAPA process
Support Quality and Manufacturing Engineering to write and Execute Test Method Validation protocols and reports
Execute and/or approve Quality Plans, Engineering studies, Protocols and Test reports
Support and evaluate process changes for qualification
Create and updates SOP’s, WI, and forms as required
Supports FDA, EMA, ISO 13485, and other client and health authority inspections/audits
Evaluate and qualify incoming inspection processes to ensure technical requirements can be met
Planning, execution, and responding to QMS documents and problem resolutions
Manage corrective actions, deviations, and non-conformances
Issues corrective actions and drives root cause investigation and corrective action implementation
QE is responsible for timely resolution of discrepant materials by working with MS&T and Quality Assurance
Planning, execution and ensuring department goals and objectives are met
Attend project meetings and establish activity timelines to meet department and company Goals and Objectives
Demonstrated experience in a regulated environment (i.e. 21 CFR 210, 211, 820, ISO 13485, MDR)
Working knowledge of cGXP requirements
Familiarity with statistical methods
Bachelor’s degree in engineering or related discipline
Strong manufacturing background, strong quality background
Clean room experience
Strong familiarity with production operations.
The items described here are representative of those that must be met successfully to perform the essential functions of this job.
Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target annualized base pay hiring range for this position is $95,000.00 - $132,500.00. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.