Manufacturing Quality Remediation Project Manager
A Manufacturing Quality Remediation Project Manager is needed for an American medical technology company primarily focused on women's health, selling medical devices for diagnositcs, surgery, and medical imaging, in the Newark, DE area. This position will manage the technical remediation of risk files and procedures to ensure the facility meets all FDA and ISO medical device standards. location: Newark, Delaware
job type: Contract
salary: $57.36 - 89.71 per hour
work hours: 8am to 5pm
education: Bachelors responsibilities:
- Lead critical manufacturing remediation workstreams and manage a team of 8 Quality Engineers (QEs).
- Spend significant time on the manufacturing floor overseeing gap assessments and process updates.
- Ensure rigorous adherence to FDA 21 CFR Part 820, ISO 13485, and ISO 14971 standards.
- Develop strategies for reviewing risk files, procedural documents, and validations.
- Identify compliance gaps and create execution plans to perform necessary procedural updates.
- Coordinate cross-functionally with R&D, Regulatory, Operations, IT, and Supply Chain.
- Manage project schedules, risk registers, and dashboards using tools like Microsoft Project or Smartsheet.
- Lead root cause analysis and risk evaluations to prevent defects and reduce process variation.
- Facilitate working sessions, risk assessments, and verification planning.
- Communicate project status and compliance risks to senior leadership and external stakeholders.
- Maintain configuration control and documentation traceability throughout the remediation lifecycle.
- strong understanding of FDA QSR, ISO 13485, ISO 14971, and EU MDR.
- Excellent collaboration and interpersonal skills.
- Adapts communication style to suit different audiences.
- Creates precise, accurate technical documentation.
- Able to facilitate group discussions.
- Ability to lead and motivate a high performing project team and supervise execution of projects, keep to timelines and prioritize resources.
- Comprehensive knowledge of manufacturing, investigation, and quality improvement methodologies such as GMP, GDP CIMS, Lean, Root Cause and Root Cause Failure Analysis, TQM, SPC and Six Sigma.
- Ability to simultaneously manage multiple large-scale projects in various lifecycle stages.
- Proficient in building integrated schedules, risk registers, dashboards, and PMO governance artifacts (Microsoft Project, Smartsheet, Planview, etc.).
- Skilled in root cause analysis methodologies, data-driven decision-making, and structured problem solving.
- Detail oriented, highly organized, and able to manage multiple priorities under urgent timelines.
- College Degree.
- Technical Bachelor's Degree.
- 8+ years of experience in project or program management in a regulated medical device environment or engineering experience supporting manufacturing.
- Demonstrated experience leading projects involving FDA 21 CFR 820 and ISO 13485 compliance, including manufacturing, CAPA, or QMS remediation.
- Experience with manufacturing, Quality Systems, and risk-based process improvements.
- Prior experience in large-scale cross-functional quality remediation or transformation programs beneficial.
- Experience level: Experienced
- Education: Bachelors
skills:
- Manufacturing
- Quality
- Validation
- Lean
- Six Sigma
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected].
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
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