Asst Quality Supervisor - Document Control - Nypro Healthcare

About Our Company

Nypro Healthcare, a Jabil Inc. company, offers healthcare and pharmaceutical customers the widest array of design and manufacturing capabilities in the industry. With more than 40 years of experience, our highly specialized teams meet the complex and regulated demands of the diagnostics, medical devices and pharmaceutical markets enabling the world's leading brands to fulfill their market potential. Nypro Healthcare s customer focused services range from ideation to device development support, engineering, supply chain optimization, vertical plastics and electronics to device assembly operations, all at our purpose-built facilities that support stringent healthcare requirements and protect our customers intellectual property.

Job Summary

Provide expertise and guidance for site document control practices specific to a regulated medical device industry. Responsible for the supervision of the Document Control team including training, mentoring and career development. Serve as the gatekeeper for all controlled site documentation throughout document life-cycle. Responsible for the daily operation of the site Document Control activities/deliverables. This position also serves as the Document Control subject matter expert (SME) for the site.

Essential Duties & Responsibilities

  • Provide expertise and guidance for site document control practices specific to a regulated medical device industry;
  • Execute demonstrated working knowledge of document control practices by completing/processing day-to-day departmental requests/tasks;
  • Act as the gatekeeper for all company controlled documentation to ensure integrity is upheld through the monitoring of the following practices: documentation reviews, approvals, issuance, retirement/obsolescence, maintenance and storage (entire document life-cycle);
  • Serves as the first line of contact in the case of escalated Document Control related issues/concerns;
  • Establish and maintain a Document Control Department capable of effective, efficient, timely and consistent customer (internal/external) service delivery;
  • Ensure compliant use of Engineering Release Order (EROs) and Change Control Notices (CCNs) for documentation submission/changes;
  • Oversee and maintain accurate documentation distribution lists, approval matrix and signature logs;
  • Maintain an up to date Master Documentation List;
  • Maintain function/operation of electronic documentation management system(s) - user profiles, databases, access control, etc.);
  • Responsible for the issuance and retrieval of hard copy documents, as applicable;
  • Serve as Document owner for all Document Control specific documentation;
  • Manage QA documentation workload and priorities to support business needs;
  • Develop departmental goals and objectives;
  • Ensure documents remain aligned with Healthcare Global Polices;
  • Oversee staff work performance and administer Performance Reviews annually;
  • Manage and oversee the site Document Retention program per applicable requirements/schedules.
  • Manage and oversee the site Document Archival/Destruction program per applicable requirements.
  • Cross train Document Control staff to ensure adequate coverage of all departmental responsibilities;
  • Lead the documentation support of internal and external audits (ISO, FDA, customer, etc.).
  • Lead the Required Document Review (RDR) (periodic review) process to ensure documents are maintained in an accurate/current state.
  • Oversee the assignment and issuance of training for all new /revised documentation;
  • Participate in internal/external meetings pertaining to Document Control responsibilities;
  • Work with customers to ensure customer requirements are being met;
  • Receive, control and distribute external (customer and Global Business Unit (GBU) documentation) (specifications, blueprints, software, work instructions, procedures, forms, specialty/reference documents (ANSI, ASTM, federal specifications and standards, etc.));
  • Collect, analyze, interpret and disseminate Document Control specific data/metrics/reports.
  • Streamline and standardize Document Control Team practices (review process, issuance, dissemination, etc.);
  • Identify areas within the current system (Document Control) for efficiency gains and recommend solutions;
  • Contribute to and/participate in company driven continuous improvement initiatives;
  • Oversee and exercise document control security surveillance during processing, reproduction, distribution and storage to ensure proper control and confidentially is achieved;
  • Possess the ability to work with copiers, scanners, printers, computers, digital cameras, etc. for documentation completion/ processing;
  • Accountable for overall departmental delivery and performance results;
  • Perform other duties as assigned.

Education & Experience Requirements

- Bachelor's degree preferred or equivalent experience
- 2-3 years working experience in related field.

Jabil is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, creed, religion, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other status protected by law.

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