Job Summary

The Senior Incoming QC Lab Supervisor is responsible for overseeing all QC activities related to verification of requirements of incoming, in process, finished good materials, ensuring compliance with company procedures, work instructions and inspection plans and directing the QC staff as required to execute all required tasks. The Senior Incoming QC Lab Supervisor is also responsible for staff training and resource utilization. They should have advanced knowledge of mechanical inspections, processes, equipment, GD&T, and blueprint reading. 

The salary range for this position is currently $100,000- $125,000 annually. Individual compensation is based on the candidate’s qualifications for the position, including experience, skills, knowledge, education, certifications, internal equity, budget, and/or other business and organizational needs.

Key Accountabilities
•Mechanical inspections, processes, equipment, GD&T, and blueprint reading.

•Ability to lead and guide staff to ensure compliance with the company quality management
system.
• Lead cross-functional efforts to resolve product performance issues and lead corrective
actions to update Standard Operating Procedures (SOP) and training materials.
• Support the Material Review Board in the execution of approved dispositions of NCR material.
• Ensure department staff are technically capable and appropriately trained to their assigned
inspection responsibilities.
• Superior QC technical skills.
• Manage QC production deadlines and schedules.
• Lead assigned CAPAs to successful completion.
• Creation of QC validation protocols and reports.
• Ability to develop complex QC inspection methods.
• Other duties as assigned.

Networking/Key relationships
• Operations
• Quality Assurance
• Quality Engineering
• Materials Management
• Document Control
• Research and Development
• Manufacturing Engineering

Minimum Knowledge & Experience required for the position:
• Bachelor’s degree or equivalent combination of education and experience required.
• A minimum of twelve (12) years progressive Quality experience within a Good Manufacturing Practice (GMP) QC lab setting required.
• A minimum of two (2) years previous supervisory experience required
• Previous experience within a regulated medical device manufacturing or In-Vitro Diagnostic
Device (IVDD) strongly preferred.
• Previous Quality Assurance experience within a 21 CFR Part 820 and ISO 13485 regulated
environment required.

Skills & Capabilities:
• Strong written, verbal and presentation skills are required.
• Strong planning, organizational and time management skills..
• Ability to appropriately prioritize department duties including urgent matters.
• Demonstrated competence with interpreting requirements and applying standard quality
control practices and methodologies to determine material acceptability.
• Clear understanding of ISO 13485, Good Manufacturing Practices (GMP) & Good Documentation Practices (GDP).
• The ability to train and mentor staff in complex inspection/verification methodologies.
• Strong understanding of process, gage and equipment validation requirements.
• Experience with Enterprise Resource Planning (ERP) system (such as SAP) preferred.
• Computer literacy required; good working knowledge of Microsoft Office programs required.

Travel requirements:
Less than 5%.

People Manager Core Competencies:
Building Talent
Planning and supporting the development of individuals’ knowledge, skills, and abilities so
that they can fulfill current or future job responsibilities more effectively.
Customer Focus
Ensuring that the internal or external customer’s perspective is a driving force behind strategic priorities, business decisions, organizational processes, and individual activities; crafting and implementing service practices that meet customers’ and own organization’s needs;
promoting and operationalizing customer service as a value.
Decision Making
Identifying and understanding problems and opportunities by gathering, analyzing, and interpreting quantitative and qualitative information; choosing the best course of action by
establishing clear decision criteria, generating and evaluating alternatives, and making
timely decisions; taking action that is consistent with available facts and constraints and optimizes probable consequences.
Driving for Results
Setting high goals for personal and group accomplishment; using measurement methods to
monitor progress toward goals; tenaciously working to meet or exceed goals while deriving
satisfaction from that achievement and continuous improvement.
Driving Innovation
Creating an environment (culture) that inspires people to generate novel solutions with
measurable value for existing and potential customers (internal or external); encouraging
experimentation with new ways to solve work problems and seize opportunities that result
in unique and differentiated solutions.
Emotional Intelligence Essentials
Establishing and sustaining trusting relationships by accurately perceiving and interpreting
own and others’ emotions and behavior; leveraging insights to effectively manage own responses so that one’s behavior matches one’s values and delivers intended results.

People Manager Accountabilities:
Effectively carries out the expectations of Werfen People Managers as defined in Werfen’s
Role of the Manager program. Among others this includes maintaining regular, at minimum
once a month, and transparent communication with the team through effective use of formal one-on-one meetings with direct reports and team meets. Managing performance issues
and conflict proactively; uses judgement in consulting with department leadership and Human Resources. Responsibility for the team´s compliance in terms of training, and fulfilment
of their tasks and objectives as well as onboarding of new employees and development of
the existing team.