3 openings in quality, go on their website to see all openings. www.enableinjections.com
Workstream Quality Engineer
Manager of Quality Engineering
PURPOSE OF POSITION:
· The Workstream Quality Engineer (WQE) is responsible for ensuring synergy across all Enable Injections medical device projects and its Customers. The WQE ensures that Design Controls and Risk Management requirements are consistently employed and applied across all Customer programs and projects. The WQE ensures that all Regulatory Requirements are integrated into the Enable Injections medical device design and the Quality Management Systems (e.g., Design Controls, Risk Management, and Statistical Analysis) are compliant at the Customer Level.
· Direct connection with Drug-Partners and ensuring that all Drug-Partner requirements are managed. A Project Team member that is responsible for Design Control commitments are satisfied.
Scope of Leadership
· Moderate supervision with some latitude for independent judgement. Limited problem-solving responsibility while working under defined guidelines.
· Bachelor’s Degree and/or education/experience equivalent.
· A minimum of 5 years of medical device design and development experience, preferable with fluid / drug delivery devices. A minimum of least 5 years of experience in Class I and II medical device designs using FDA design controls.
· Quality Engineer Certification (CQE)
Skills & Competencies:
· GD&T background, experience with Gage R&R studies, and understanding of SPC principle.
· Risk Management.
· Knowledgeable with device manufacturing systems and methods and statistical analysis techniques.
· Possess a good balance of technical expertise, analytical thinking and communication skills for resolving issues internal and external to the organization.
· Competent with word processing, spreadsheet and statistical analysis software packages (preferably Word, Excel and Minitab)
· Working knowledge of blueprint interpretation in accordance with ANSI/Y-14.5
· Identification and traceability of Input Requirements from Feasibility through Design Release for Platform Requirements. Responsible for ensuring that Platform Input requirements are defined, verifiable, and are not redundant.
· Traceability of Risk Management through Design Controls and assurance that all risks have been reduced as far as possible for Platform Requirements.
· Review of Input Requirements to ensure that requirements are tested under proper stress conditions to satisfy design, regulatory and pharma-partner requirements are correctly assigned for each finished product.
· Involved in Design Verification Activities to test samples sizes and demonstrations correctly reflect the level of performance required to meet pharma-partner’s safety profiles.
· Support Process/Product Validations through Sample Size determination, Normality Testing and Data Analysis. Establish Statistical Process Monitoring & Control in production.
· Support Product Development projects and teams as required.
· Support investigations and corrective actions per the corrective and preventative action program.
· Support trend analysis tools to report on operational performance, product quality and monitor the effectiveness of corrective actions related to deviations, internal audits, customer complaints, and supplier performance.
· Proactively communicate project status to Sr. Management.
· Manage other job functions and duties as required.