Job Summary:
The Project Manager, Manufacturing Quality Remediation, is responsible for leading one or more critical workstreams within the company s remediation program, specific to manufacturing support. This individual provides disciplined project management, cross-functional alignment, and rigorous adherence to FDA 21 CFR Part 820, ISO 13485, ISO 14971, and applicable global regulatory requirements.
The Project Manager at this level is a seasoned, experienced professional with a full understanding of manufacturing and QMS requirements. This person has the ability to resolve a wide range of issues in creative ways and work and influence members of various departments in an effective way. This individual normally receives little instruction on day-to-day work, general instructions on new assignments. This individual demonstrates good judgment in selecting methods and techniques for obtaining solutions. They will build relationships and networks with senior internal and external personnel in their own area of expertise.
Essential Duties and Responsibilities:
The table below outlines the key activities and competencies required for each knowledge category. The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
Model all quality values and supports others on BSH quality system requirements and standards to elevate team's ability to produce high-quality products and implement best practices that emphasize defect prevention, reduction in variation and waste and provide for continuous improvement.
Responsible for the coordination of assigned Quality efforts and provides support for the BSH global supply chain department as directed by the Manufacturing Quality Director.
Lead planning and execution of manufacturing remediation workstreams, establish objectives, deliverables, success criteria, and project schedules
Assist in managing a team of remediation Quality Engineers that identify gaps within manufacturing processes and implement corrections, corrective actions, and process improvements.
Coordinate with Quality, Regulatory, R&D, Operations, Service, IT; facilitate working sessions, risk assessments, problem-solving, verification planning; deliver status updates, dashboards, presentations; maintain configuration control and traceability
Identify risks, barriers, dependencies; develop mitigation strategies; communicate compliance risks; support root cause analysis, risk evaluation, documentation quality
Partner with process owners and SMEs for long-term solutions; recommend enhancements to procedures, templates, governance, training, system integrations; contribute to continuous improvement and quality accountability
Physical Demands:
The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Sit; use hands to finger, handle or feel objects, tools, or controls.
Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.
Lifting/moving and carrying products weighing up to 40 pounds.
Exposure to moving mechanical parts, vibration and/or moderate noise levels.
Exposure to hazardous chemicals or other materials.
Safety Shoes with Impact and Compression Protection Must be worn in designated areas.
Exposure to blood.
Travel (please specify):
Other (please specify):
Qualifications:
Education
Preferred Minimum Non-Technical Degree: College Degree
Preferred Minimum Technical/Advanced Degree: Technical Bachelor s Degree
Experience
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.
Skills
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.
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How quickly are you looking to interview/hire? : ASAP
How many rounds of interviews do you plan to conduct? : Phone screen with HM, then onsite for panel interview with 3 other people.
Any possibility of assignment being extended or eventual conversion to FTE? : potential to extend up to 24 months. Little to no potential for conversion
Is this a 100% onsite role?: YES
Can this position work hybrid? (please provide arrangement if so): Potential for 10-20% hybrid, but preference is for 100% onsite
Can this position be fully remote?: NO
Aside from the job description, please provide an overview of what a day for this contractor will look like:
- Manage team of 8 Qes who are out on floor. With them on floor often. Strategizing reviews of risk files, procedurals, validations, understanding and identifying gaps, strategy to perform updates to procedures, fill in gaps identifed by Qes during gap assessment
Must have skills: Manufacturing support, project management experience, risk management experience
Teachable skills: Doesn t need to have managed large teams - but should have at least been a mentor or in mentorhisp role. Managing a team can be optional
Optional skills:
Desired years of experience: ~8+ years
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