devices are designed in accordance with product requirements, ISO 13485, and 21 CFR 820. They develop and maintain risk management plans, audit against the requirements for the DHF, and provide feedback on product requirements, risk backssments, and verification methods.
- -DUTIES AND RESPONSIBILITIES: ----Guides the design control process for product development projects. ----Owns the risk management file and works with the R&D team to perform risk backssment for product design and manufacturing processes. ---Writes risk management plans, quality plans, verification plans, and may author associated reports. ---Supports design verification activities, including management of biocompatibility
testing, and packaging validation testing. - ----Reviews, provides feedback, and approves project design and development deliverables as the quality lead.
----Performs risk and impact backssments for design changes to products. - ----Assures that the DHF clearly documents the trace relationships between design inputs and design outputs. ----Co-owns, with the project manager, the processes and documentation for design reviews, DHF content structure, and project phase gate reviews. - ----Collaborates with engineers on troubleshooting test anomalies and development build nonconformances. - ----Reviews and approve development build records. - -QUALIFICATIONS: ----Bachelor's Degree (BS) in
life science discipline or equivalent combination of education and experience.
- ----5+ years of experience in medical device development, with experience primarily in quality assurance/design verification. ----Experience working in quality systems as defined in 21 CFR 820 and ISO 13485 ----Experience working on sterile, single-use products such as implantable leads. - ----Experience working within the requirements of: ISO 11070, ISO 10993, and ISO 11135. ----Familiarity with IEC 60601-1. ----Understanding of ISO 14971 and application of risk management techniques to product development, including creation of risk management deliverables. ----Demonstrated technical expertise and leadership in quality ----High attention to detail, organization, and accuracy.
----Strong ability to communicate (written and verbally) within and across disciplines and organization structures ----Demonstrated use of quality tools and methodologies (e. g. nonconformance, CAPAs, design issue tracking, root cause analysis) ----Familiarity with statistical software, such as Minitab, preferred. ----Intermediate to advanced proficiency with MS Office Suit (Word, Excel, Power Point, Project, Outlook) - -COMPETENCIES: ----Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs work flows and procedures.
----Oral Communication - Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings. ----Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information. ----Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.
----Diversity - Demonstrates knowledge of EEO policy; Shows respect and sensitivity for cultural differences; Educates others on the value of diversity; Promotes a harassment-free environment; Builds a diverse workforce. ----Ethics - Treats people with respect; Keeps commitments; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
----Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality. PHYSICAL -DEMANDS AND WORK ENVIORNMENT: ----Occasionally required to stand ----Occasionally required to walk ----Frequently required to sit ----Occasionally required to talk or hear Contact: This job and many more are available through The Judge Group. Find us on the web at
