Medical Device Quality Engineer :: Remote Opportunity
Duration: 06 + Months Contract (possible extension)
Qualifications: Actual Job Title: Medical Device Quality Engineer. Position available: 2 Qualifications:
- A Bachelor’s degree in (Science or Engineering or associated fields) with a minimum of 7 years related experience OR a Master’s degree (Science or Engineering or associated fields) and 5 years related experience or a Ph.D. (Science or Engineering or associated fields) and 3 year of related experience.
- Advanced degrees may be used reduce required experience. Skills
- Lead and manage development of DHF (design history file) deliverables for medical devices.
- Extensive knowledge of applicable medical device regulations (21CFR820, MDD, ISO 13485:2016).
- Experience with Design Controls / CAPA / Purchasing Controls as it related to 21CFR820.
- Risk Management experience (ISO 14971:2012) Personality:
- Effective communication skills and working knowledge of device development and commercialization, product approval, and/or regulatory inspection experience with the medical devices.
- Must be able to work independently within a cross functional framework and will involve detailed technical writing and review.
- A high degree of creative thinking, resourcefulness, and networking will be required to coordinate projects or solve problems.
- Ability to work in a matrix organization and effective written and oral communicator.
Preferred experience and skills:
- Remediation experience is desired.
- Knowledge of current GMPs for combination products.
- Certified Lean Six Sigma Green Belt or Black Belt or ASQ (American Society for Quality) certifications are preferred. • Strong understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (QDP); and project management principles is desirable.
- Lean Six Sigma Principles and tools such as: DOEs, Root cause analysis and/or Problem solving methods are desired.
- Experience in the use of root cause analysis and applied statistical technique
NOTE: \*100% REMOTE ROLE\*. POSITIONS:
2. Red Flag: DO NOT submit anyone with Automotive/automation industry experience. 6 months assignment with extension possibility.
Responsibilities: MDCP Quality- Medical Device Combination Product (MDCP) department is looking for an experienced medical device quality engineer. Position Overview - Basic Functions & Responsibility Essential function(s) includes but is not limited to: • This position will be a high level, individual contributor role on the Medical Device and Combination Product Quality team. • Reporting to the Director MDCP Quality Assurance Product Platform, the Associate Director Quality Assurance is responsible for independent compliance support of Medical Devices including the device constituent part of Combination Products. • This position will interact with cross functional teams working with all levels of employees. • Activities will include developing, documenting, and maintenance of technical business solutions or audits of data, policies, procedures, and systems to ensure compliance with Medical Device (21CFR 820s) and Combination Product current Good Manufacturing ruling (21CFR part 4), Device Risk Management (ISO 14971) and other worldwide regulations and Client requirements. • This position provides Device QA support and leadership to ensure successful quality oversight of prospective medical devices and medical device combination products. Primary Activities Primary activities include but are not limited to: • Actively represent MDCP Quality function on commercial and product/core development teams supporting quality issues related to medical devices or the device constituent of a combination product. • Review and approve Design Control and Device Risk Management documentation for regulatory filings, clinical supply, development, design transfer qualification and post marketing surveillance. • Evaluate deficiencies and assess impact on compliance status. • Contribute to developing/revising policy and procedures for MDCP Quality and/or supported areas. • Remain informed of industry trends as described in worldwide regulations and industry standards. • Provide guidance to MMD and MRL device functions and other personnel to ensure end-to-end Design Control principles are implemented effectively. • Participate in design reviews, CAPA reviews, and ad-hoc technical reviews of combination products. • Participate in all stages of combo product development including but not limited to oversight of purchasing controls and supplier quality. • Work with external partners to develop products. • Review and approve verification/validation test protocols and reports to ensure that the testing is sufficient to meet regulatory requirements and quality objectives. • Provide input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested. • Facilitate translation of customer needs into critical to quality and design input/output requirements, including but not limited to chemical, physical, or performance specifications.
Talent Acquisition – US Pharma Division
Phone: +1 551-272-8778
Job Type: Contract
Pay: $70.00 - $110.00 per hour
- Medical Device Quality Engineer: 1 year (Preferred)
Work Location: Remote