Merck
Associate Director, Metrologist and Compliance Lead, Medical Devices and Combination Products
USA - New Jersey - Rahway · Director · Contract
Sponsorship not specified$142k-$224kDetected 2 days ago
Data AnalysisStatisticsProject ManagementProcurementHRISMechanical DesignFDA RegulatoryMicroscopyMedical DevicesCommunicationProblem SolvingMentoring
About the role
- Please click here if you need an accommodation during the application or hiring process.
- The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment.
- We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Responsibilities
- Device design controls and design verification requirements.
Requirements
- B.S. in Mechanical Engineering, Biomedical Engineering, Quality Engineering, Metrology, Physics, or a related scientific discipline with 8+ years of relevant industry experience
- M.S. in a related discipline with 5+ years of relevant industry experience.
- Demonstrated expertise in metrology principles, calibration systems, measurement uncertainty, and traceability requirements.
- Experience with equipment qualification (IQ/OQ) and computer system validation activities.
- Experience managing deviations, nonconformances, investigations, CAPAs, and change controls.
- Proven ability to work across multidisciplinary technical teams.
- Experience supporting notified body, FDA, and international regulatory inspections.
- Requirements:
- Experience supporting ISO 13485-certified medical device or combination product development laboratories.
- Strong knowledge of design controls, risk management, and medical device quality management system requirements.
- Skilled in laboratory documentation practices and electronic quality systems.
- Strong organizational, communication, project management, and problem-solving skills.
- Medical device or combination product development.
- Design verification and test method validation activities.
Nice to have
- Preferred experiences include:
Skills
- Current Employees apply HERE
- Current Contingent Workers apply HERE
- US and Puerto Rico Residents Only:
- Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.
- For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
- EEOC Know Your Rights
- EEOC GINA Supplement
Compensation
- The salary range for this role is
Benefits
- ISO 13485 - Medical Device Quality Management Systems
- ISO 14971 - Risk Management for Medical Devices
- EU Medical Device Regulation (EU MDR)
Company info
- As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.
- As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.
- For more information about personal rights under the U.S.
- 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 cand
Equal opportunity
- Employment laws, visit:
- We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
- Learn more about your rights, including under California, Colorado and other US State Acts
- The salary range for this role is
This listing is sourced directly from Merck's careers page and normalized into a canonical job model.