Job Description

Reporting to the Director of Medical Device and Combination Product Quality Assurance, 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 requirements. This position provides Device quality engineering, 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 Medical Device and Combination Product 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 Medical Device and Combination Product Quality and/or supported areas. * Remain informed of industry trends as described in worldwide regulations and industry standards.

• Provide guidance to stakeholders 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 combination 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 (Design History File) deliverables for medical devices

Skills

• Extensive knowledge of applicable medical device regulations (21CFR820, 21CFR Part 4, EU MDR, ISO 13485).

• Experience with Design Controls / Corrective Action and Preventive Action / 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 Good Manufacturing Practice for combination products.

• Strong understanding of Good Manufacturing Practices, Good Documentation Practices ( Quality Data Portal ); and project management principles is desirable.

• Lean Six Sigma Principles and tools such as: Design of Experiments , Root cause analysis and/or Problem-solving methods are desired.

• Experience in applied statistical techniques and the use of root cause analysis

• Certified Lean Six Sigma Green Belt or Black Belt or American Society for Quality (American Society for Quality) certifications are preferred.

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.

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We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.

Expected US salary range:

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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Requisition ID:R334678