A bit about us:
We have an outstanding career opportunity for a Quality Engineer with medical device or related manufacturing process analysis experience to join a leading Medical Device Manufacturing Company located in the beautiful St. Louis, MO. area.
The position is responsible supporting lifecycle risk management for medical device products and manufacturing processes.
The position is responsible for periodic review of risk management files to conform with the latest state-of-the-art and assumptions of risk in conformance with ISO 14971.
The position is responsible supporting lifecycle risk management for medical device products and manufacturing processes.
The position is responsible for periodic review of risk management files to conform with the latest state-of-the-art and assumptions of risk in conformance with ISO 14971.
Why join us?
We offer an exciting and dynamic work environment along with an area competitive compensation plan and an amazingly above average benefits package.
Job Details
Responsibilities:
Requirements:
** One of the following certifications is desired for this role: Certified Quality Engineering (CQE), Certified Quality Auditor (CQA), Certified Software Quality Engineer (CSQE), Certified Reliability Engineering (CRE), Certified Biomedical Auditor (BCA), or Six Sigma Black Belt.
- Perform assessment of appropriate risk information to support on-going Post Market Surveillance and Periodic Safety Update Reports in conformance with ISO 14971.
- Own process risk assessments as needed and performs periodic review to ensure effectiveness of risk mitigation activities.
- Facilitate risk assessment meetings, documentation of the process and decisions, and follow up of actions.
- Develop functional area process risk assessments in compliance with MDSAP requirements.
- Support quality improvement initiatives related to risk management of product and process including but not limited to CAPA investigation and actions, Nonconforming material investigations, input on risk for field actions and customer complaints, maintenance of the risk management file index.
- Update risk management summary reports as needed.
- Perform similar device review with the support of subject matter experts in compliance with ISO 14971 and internal procedures.
- Develop working relationships with key business partners across the firm.
Requirements:
- 5+ years of experience in medical devices, medical instruments, pharmaceuticals, biotechnology or related industry is required.
- Direct ISO 14971 Risk Management experience.
- Requires working knowledge of selection and use of Quality Engineering tools, statistical analysis techniques, data trending or manufacturing process.
- Experience developing risk assessments (FMEA, FMECA, product safety risk, etc.) to drive improvements and/or maintain processes.
- Requires knowledge of the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, IVDR, MDSAP, etc.).
** One of the following certifications is desired for this role: Certified Quality Engineering (CQE), Certified Quality Auditor (CQA), Certified Software Quality Engineer (CSQE), Certified Reliability Engineering (CRE), Certified Biomedical Auditor (BCA), or Six Sigma Black Belt.
- Requires effective written and oral communication skills to interact across all levels of the organization.
- Must possess High level of attention to detail, highly motivated and organized.
- Must have experience in and knowledge of Microsoft Office Package (Word, Excel, etc.)
Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age (40 and over), disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws. Jobot also prohibits harassment of applicants or employees based on any of these protected categories. It is Jobot’s policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions.
Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.
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By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Jobot, and/or its agents and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here: jobot.com/privacy-policy
Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.
Information collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal.
By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Jobot, and/or its agents and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here: jobot.com/privacy-policy