Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
- Provides strategy and leadership over the Quality Engineering (QE) teams at both Rockford Linden sites that are involved in supporting design transfer/control/assurance, risk management, statistical analysis of data, deviations, complaints, change management, and quality improvement projects.
- Direct oversight and development of Quality Engineers responsible for Advanced Drug Delivery business segment assigning them to projects based on technical expertise and project priority
- Leads QE team to support New Product Introduction and tech transfer for product launches as well as supporting the sustaining commercialized products
- Accountable for overall management, reviewing, planning and administering of resource allocation and workload planning for the Quality Engineering staff.
- Serve as subject matter expert (SME) and process owner for the Design Control and Risk Management procedures within the Quality Management System, including a risk management program aligned to ISO 14971
- Oversee and approve PCI investigations including calibration OOS and laboratory or environmental monitoring product impact investigations.
- Oversee and approve site supplier nonconformances and supplier related quality metrics
- Process owner for Measurement System Analysis (MSA), Control Plans, Process Flow Maps, Inspection plans and techniques, GR&R, test requirements and Test Method Transfer/Validation.
- Technical evaluation of change controls including risk assessment / implementation of risk mitigation strategies.
- Provide high level guidance on complex design validation and verification (V&V) strategies, sampling plans and root cause investigations for design failure.
- Oversee the feedback loop between Post-Market Surveillance (Complaints) and internal or external design assurance teams to trigger necessary design changes or CAPAs based on field reports.
- Serve as the final Quality approver for major "Stage Gate" transitions, ensuring all design inputs, outputs, and transfer activities are complete and compliant.
- Ensure design assurance strategies align with evolving global standards, including ISO 13485 and FDA 21 CFR 820
- Apply scientific statistical analysis techniques to proactively identify trends, identify root causes and implement actions to mitigate recurrence.
- Oversees and provides input for statistical assessment of data to drive improvements.
- Supports and maintains quality assurance programs and systems, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency requirements to ensure customer and regulatory satisfaction.
- Participates as a member in various steering committees to guide and influence the company's focus on new products, new customers, and strategic initiatives.
- Prepares reports to company management detailing the status of open projects that support the capacity, regulatory and quality improvement requirements of the plant.
- Presentation of quality standards, process flows, inspection plans, and/or issues both internally to stakeholders and externally to clients with confidence and accuracy.
- Establishes and ensures the Quality Engineering team achieves the appropriate levels of compliance and develops actions to ensure ongoing performance is achieved and maintained through metrics and other forms of KPI's.
- Support the recruitment, coaching, and development of Quality Engineers to achieve excellence and efficiency when programs are scaled.
- Creates a "learning" culture that enables individuals to reach their maximum potential and builds the capability of the organization and generates energy, enthusiasm and commitment from others.
- Ensures budget development and the preparation of periodic projections of spending against budgets; and manages and controls departmental spending.
- Partners with internal teams (Business Unit, Quality, Operations, Engineering, Validation) to achieve company goals
- Participates in regulatory inspections, customer audits, visits and conference calls.
SUPERVISORY RESPONSIBILITIES:- Leads a group up to 10 direct reports across multiple sites.
Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Required:- College or Trade Degree required (engineering degree or related scientific degree). Must have a minimum of 5+ years of experience in an FDA regulated industry with strong preference to medical device or combination products.
- Demonstrated proficiency with personal computers, business software (e.g., MS Office) and technical software (ERP and eQMS systems). Ability to create, use and interpret scientific tables, charts, and graphs.
- Advanced Computer Skills: Ability to perform the most complex computer tasks and operate various computer programs.
- Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
- Analytical ability to drive effective Root Cause Analysis (RCA) and critical thinking for complex problem solving.
Preferred:- Possesses excellent organizational, time management and multi-tasking skills to meet commitments and deadlines.
- Prior experience in technical writing and utilizing root cause analysis tools is required.
- Critical thinking skills along with a strong collaborative approach is required.
- Lean Six Sigma or other formal process improvement skillsets are highly desirable.
- Technical knowledge and experience around Test Method validation, MSA, and Medical Devices processes is preferred.
The hiring rate for this position is $108,690-$136,200 plus eligibility for an annual 10% performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan.
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