Summary:

The primary function of this position is to effectively manage inspection resources so as to insure that only quality products are released for distribution and that those released products meet all regulatory requirements. The secondary function of this position is to efficiently manage resources to support our change management systems such as protocol studies and approval submissions. Thirdly, this position requires negotiated work in maintaining adequate control of: certified processes, suppliers, environments, instrumentation, record/samples, calibration, sterile products, complaints and the QA Document Center.

Responsibilities:

* Management of day to day inspections in both In-Coming and In-Process testing laboratories. Ensuring adequate resources are available to support engineering projects and production requirements. Support team and promote execution of inspections in a timely manner in support of customer service.

* Support Hollister Production System (HPS) initiatives.

* Direct supervision of hourly workforce in a union environment.

* Produce graphs and charts for plant metrics. Monitor SAP entries for accuracy and data entry.

* Perform Internal Audits and Supplier Audits (Become ISO13485 Lead Auditor)

* Participate on teams in support of Global Quality and Supplier Quality.

* Monitor sterilization results in conjunction with the Quality Systems Administrator and provide support to that role during vacations and absences.

* Monitor calibration requirements and ensure they are done correctly and on time.

* Create and approve specification changes as required.

* Approve FTIR scans for resins and plastic materials.

* Perform investigations for customer complaints – including the gathering of data from SAP for lot trace and retrieval of production / inspection forms for product. Handles updating QN’s in SAP as necessary.

* Support MyQumas and SAP questions and assist personnel with issues and problems.

* Create Certificates of Conformance for Regulatory on request and for sterile products, products shipping to customers and sister plants. Some require graphs charting the inspection data also.

* Support plant initiatives and goals

* Support production on a daily basis with quality decisions and guidance

* In conjunction with the Supply Chain Specialist perform Supplier Evaluations internally on a quarterly basis.

* Oversee the quality aspects of sterile product inspections and releases.

* Oversee the QA Document center.

Essential Functions of the Role**:

Must be able to lift 10 – 20 lbs.

Walking

Sitting at computer workstation to perform daily job requirements

Standing

Speaking and listening

Seeing, field of vision, heat and cold (varies)

Travel Requirements

Talking on phone with internal and external customers

Ordering supplies

Work Experience Requirements

Number of Overall Years Necessary: 0-2

Supervision of direct reports or similar experience

Auditing experience (preferred)

Experience in medical device or pharmaceutical field (preferred)

Good communication skills

Education Requirements

Bachelor degree (Science field preferred)

Hollister is an EO employer – M/F/Veteran/Disability

Job Req ID: 28350