at Merck in Springfield, Illinois, United States
Job Description
Job Description
Position Overview – Basic Functions & Responsibility Essential function(s) includes, but is not limited to:
Reporting to Senior Management of the Medical Device and Combination Product (MDCP) Quality Assurance Operations team, the Associate Director Quality Engineering & 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, reviewing and approving medical device/combination product documentation to support regulatory filings and 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 our Compa requirements.
This position provides Device quality engineering and quality assurance support and leadership to ensure successful quality oversight of prospective medical devices and medical device combination products.
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 our Manufacturing Division and our Research & Development Division 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.
+ Lead and manage development of Global Design file (GDF) (Design History File-DHF) deliverables for medical devices
Skills:
+ Extensive knowledge of applicable medical device regulations (21CFR820, 21CFR Part 4, EU MDR, ISO 13485).
+ Experience with Design Controls / CAPA / Purchasing Controls as it related to 21CFR820.
+ Risk Management experience (ISO 1497124971, ICH Q9).
+ Effective communication skills and working knowledge of device development and commercialization, product approval, and/or regulatory inspection experience with 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 techniques.
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 years of related experience
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers’ Policy – Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
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