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Senior Supervisor, IQC Lab

3 months ago

San Diego, California, United States Werfen Full time
Overview

Werfen
Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain.


We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant.

Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors.

Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality.

We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Job Summary Job
The Senior Electro-Mechanical Quality Control Supervisor is responsible for the overall operations of the EMQC functions.

This includes overseeing all Incoming QC activities related to verification of requirements of incoming, finished good materials, ensuring compliance with company procedures, work instructions and inspection plans and directing the Incoming QC staff as required to execute all required tasks.

The Senior Electro-Mechanical Quality Control Supervisor is also responsible for training staff, budget preparation and resource utilization
Responsibilities

Key Accountabilities

  • Verification and release of incoming, in-process and finished good materials.
  • Properly label non-conforming materials and ensure material is placed in quarantine.
  • Support customer complaint investigations and prepare related reports.
  • Support Materials Review Board in the investigation of non-conforming material.
  • Support the material review board in the execution of approved dispositions of NCR material.
  • Write, evaluate and update IQC standard operating procedures (SOPs), work instructions (WIs) and inspection plan as required.
  • Ensure department staff are trained in the appropriate procedures, work instructions; ensure compliance to these during routine operations.
  • Will be required to talk and hear and have specific vision abilities, including close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
  • May occasionally have to lift and/or move up to 25 pounds.
  • Other duties as assigned.
Networking/Key relationships

  • Operations Production teams
  • Quality Assurance group
  • Bio quality control lab
  • Materials Management group
  • Document Control group
  • Research and Development
  • Manufacturing Engineering Teams
Qualifications

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) lab setting 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.
  • Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

Skills & Capabilities:

  • Computer literacy required; good working knowledge of Microsoft Office programs required.
  • Ability to lead and guide staff to ensure compliance with the company quality management system.
  • Superior written, verbal and presentation skills are required.
  • Strong planning, organizational and time management skills.
  • Ability to prioritize urgent matters.
  • Superior level of competence with engineering drawings, metrology, mechanical and electrical inspection methodologies.
  • Strong understanding of IPC 610 standard.
  • Strong Understanding of Good Manufacturing Practices (GMP) & Good Documentation Practices (GDP)
  • The ability to train and mentor inspectors in appropriate inspection methodologies and GMP/GDP requirements.
  • Strong understanding of calibration principles.

Travel requirements:
No more than 5% of total time.

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 teams 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.


Acknowledgement:

The above statements are intended to describe the general nature and level of work being performed by the incumbent.

They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of this position.

I have read and understand the job description for my position.

I agree to comply with the corporate compliance policy and all laws, rules, regulations and standards of conduct relating to my position.

I understand that this does not constitute or contain a contract or employment promise of any kind. Nothing contained herein modifies the at-will nature of my employment with Werfen.
Werfen is an Equal Opportunity employer and is committed to a diverse workplace.

Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law.

If you have a disability and need an accommodation in relation to the online application process, please contact for assistance.

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