Auditor - medical devices
We are searching for an experienced auditor - medical devices at our remote-telecommuter location.
Summary of position:
The regulatory/quality auditor position will have a background in regulatory requirements applying to manufacturers’ processes and products as well as experience in auditing manufactures to ensure continued compliance with quality system standards (iso 13485, iso 9001), and mdsap and mdd/mdr regulationsThe regulatory/quality auditor will review all facets of the client’s quality system including product design, engineering, purchasing, training, and manufacturing, documenting any deficiencies and ensuring compliance to the requirementsDekra certification, inc goal is to seek consensus on solutions while maintaining a focus on compliance.
Dekra is one of the world’s leading testing, inspection and certification (tic) companies offering innovative professional services in the fields of vehicle inspection, expert appraisals, industrial product testing & certification, management system certifications, leadership consulting, and much moreDekra is a purpose-driven organization with a deep passion to make the world a safer place on the road, at work and homeAt dekra north america, you will be part of a growing organization with a near 100-year history employing over 45,000 employees in more than 60 countries around the globe.
Leading complex regulatory and technical projects, dekra is your global partner in the testing and certification of medical devicesWe are one of the five largest notified bodies in the world for companies involved in the design, manufacturing, and distribution of medical devices, including high-risk and innovative medical devices and in-vitro diagnostic medical devicesDekra is a recognized auditing organization for the medical device single audit program (mdsap)This program is designed to allow a single audit for medical device manufacturers that is accepted in multiple regulatory jurisdictionsAs an established, well-recognized certification body, we maintain a global network of offices and state-of-the-art laboratories, taking pride in helping our client’s gain worldwide access to markets including europe, taiwan, the usa, canada, brazil, australia, and japan.
Essential duties & responsibilities:
Utilize knowledge of regulatory requirements and applying them to manufacturing processes and products.
Audit manufacturers to ensure continued compliance with quality system standards (iso 13485, mdsap) as well as regulatory requirements (mdd/mdr).
Review product design, engineering and manufacturing while documenting any deficiencies.
Create high-quality, detailed audit reports for clients drawing upon analytical skills, technical knowledge and excellent written communication skills.
Demonstrated ability to assess compliance with regulatory requirements while working with minimal supervision.
Analyze complex regulatory requirements and make sound determinations of the proper course of action.
Create agendas and reports in a timely manner.
Required knowledge, skills & abilities:
Broad knowledge of engineering and technical applications used in the development of medical devices.
Ability to develop collaborative, working partnerships with clients (both internally and externally) and on project teams.
Strong commitment to principles of client excellence; demonstrating a strong client service orientation in all interactions and activities.
Confidence in exercising judgment with the ability to identify situations requiring the expertise of others.
Strong sense of urgency including the ability to meet or exceed deadlines, set priorities to handle multiple projects simultaneously delivering results on time in an efficient and effective manner.
Utilize polished, professional presentation skills while communicating with clients to present dekra’s findings.
High degree of professionalism.comfortable with scheduling and conducting work over the phone, conference calls, and multi-media platforms including video conference calls - zoom, skype, teams, etc.
Demonstrated communication skills in both verbal and written formats.
Strong analytical and problem-solving skills.
Excellent organizational skills and the ability to work autonomously.
Desired knowledge, skills & abilities:
Strong background in either design engineering or r & d.
Global regulatory affairs background including ce medical device directives.
Experience with sterilization processes and technologies.
Broad background in medical devices sector.
Documented audit log inclusive of the following details: audit dates; number of audit days; audit type (e.g., certification, surveillance, renewal, upgrade, unannounced or corrective action); responsibility (e.g., lead, team member or technical expert); audit criteria; codes corresponding to the client (eac – iso 9001, ta – iso 13485, nbog / ta – ce); regulatory scheme (e.g., cmdcas, mdsap).
Evidence of auditor / lead auditor qualification (i.eCertificate or evidence of completion of rab-accredited course).
Professional credentials / certifications (e.g., mdsap, asq, rac).
Evidence of relevant training (e.g., iso 13485:2003_2016, iso 9001:2008_2015, mdd, ivdd, mdsap, cmdr, jpmd act.) - training certificates from 3rd party organizations or from a previous employer.
Required education & experience:
Minimum 4-year degree in either engineering, biomedical, medicine, pharmacy, (micro) biology, biotechnology, clinical physics or related discipline of medical devices.
Minimum of 5 years of progressive, professional experience in medical device/regulatory affairs field.
Experience with internal/external auditing (certified lead auditor) to iso 13485, iso 9001, gmp, mdd, ivd, mdsap regulations to include supplier audits, fda, and notified bodies.
Physical demands:
Ability to work in a general office environment.
Ability to handle extended periods of computer-based work, including telephone.
Must be able to withstand the rigors of extensive travel.
Ability to lift 25-50lbs.
Required travel:
Domestic and/or international travel required, estimated up to 50%.
Dekra north america is proud to be an equal opportunity employerAll qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.
