Senior Specialist Medical Device & Combination Products, Quality Systems Improvement Program Job - United States
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
Reporting to the Executive Director Medical Device and Combination Product Quality (MDCPQ) lead, responsibilities include:
- System Steward
- Manage activities related to electronic quality systems, e.g. document and record systems, Trackwise Change Control and Trackwise Corrective and Preventive Action (CAPA), Success Factors training, etc.
- Assist with system configuration and maintenance.
- Maintain document and record integrity in electronic systems.
- Project Management
- Prepare for CAPA and change control meetings and manage meeting records and documents.
- Collect, graph and analyze data for quality metrics.
- Manage MDCP projects for Quality System Improvement Program (QSIP) activities.
- Document Steward
- Write standard operating procedures and create forms and templates.
- Manage documents in the electronic systems through their life cycle.
- Create training materials for documents.
- Manage MDCP records.
- Training Steward
- Create and manage training curricula for each MDCP job function.
Education Minimum Requirement:
- B.S. and/or M.S. degree in an appropriate Science or Engineering discipline.
Required Experience and Skills:
Minimum of six (6) years’ experience in pharmaceutical OR engineering OR academia environment(s)?
- Effective interpersonal skills and ability to work collaboratively across diverse teams and networks; able to foster cooperation in others. Effective written and oral communicator. Able to speak up and contribute in a team forum. Able to apply prior experiences and learning’s in new settings, even if these are unfamiliar.
- Proven working experience in project management.
- Proven experience with electronic quality systems, e.g. document management, training, CAPA, change management.
- Proven experience authoring documents.
- Excellent client-facing and internal communication skills.
- Excellent written and verbal communication skills with experience presenting information at meetings.
- Solid organizational skills including attention to detail and multi-tasking skills.
- Strong working knowledge of Microsoft Office suite of software.
Preferred Experience and Skills:
- Working knowledge of technical aspects of device development and commercialization. Development, product approval, and/or inspection experience with the medical device constituent of a combination product is an asset.
- Development and delivery of training is an asset.
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at firstname.lastname@example.org.
Search Firm Representatives Please Read Carefully:
Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
Visa sponsorship is not available for this position.
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC GINA Supplement
Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
Job: Clinical, Non Clinical Quality Assurance
Job Title:Sr. Spclst, Quality Assurance
Primary Location: NA-US-NJ-Whitehouse Station
Employee Status: Regular
Travel: Yes, 15 % of the Time
Number of Openings: 1
Company Trade Name:Merck
Nearest Major Market: New Jersey
Job Segment: Medical, CAPA, Engineer, Medical Device, Change Management, Healthcare, Management, Engineering