Associate Manager Quality Engineering Hypodermic BU Business - RT

Associate Manager Quality Engineering Hypodermic BU Business - RT

Columbus, Nebraska

The Associate Quality Engineering Manager is responsible for the management, direction and coordination of all quality and regulatory compliance activities across the Columbus Hypodermic BU Business Unit in compliance with world-wide regulations, business strategies, and customer needs. This includes providing the quality leadership encompassing Quality Systems, Quality Engineering, and Sterilization control to ensure that the required production, quality and regulatory standards are achieved through molding, assembly, packaging, sterilization and product release. Reports to the site Associate Director Quality Management with dotted line reporting to the Hypodermic BU Manager.

Essential functions include, but are not limited to, the following:

Manages and leads the Quality Systems and Quality Engineering activities for the Hypodermic BU.

Manages and support validation activities related to processes, products, materials and projects supporting the Hypodermic BU and other BUs when requested.

Develops and implements strategic direction for the Hypodermic BU consistent with the Hypodermic Platform, MDS and BDX Quality strategy.

Provides effective Quality Management leadership to Hypodermic BU BLT and contributes to the Columbus Quality leadership Team in order to meet quality, business and organizational objectives of the BD Medical: Medication Delivery Solutions.

Provides effective leadership in teamwork development, effective communication and quick responses to customers. Drives improvements towards customer centricity.

Implements effective CAPA process focused on reduction of causes of customer complaints, non-conformances, excursions, rejections and waste.

Assesses and builds organizational capability for Quality management, particularly in the selection and mentoring of dedicated high caliber QE and QC Reps (Quality Engineering and Quality Representatives) professionals.

Evaluates, facilitates, designs, implements and continually improves quality systems and business processes, including product controls to achieve quality goals and to maintain a high level of regulatory compliance.

Management representative for the Hypodermic BU with regards to all Quality System regulation issues.

Enhances BD Columbus Hypodermic BU management’s understanding and application of broad scope Quality Management principles through education, training, and workshops.

Provides leadership and guidance in integrating Quality Management and continuous improvement into the Columbus business strategic planning process.

Champions the needs of both internal & external customers by factoring these needs into planning & decisions at all levels.

Builds a strong interactive working and strategic relationship with appropriate PosiFlush Platform Quality, R&D and regulatory management groups.

Builds & sustains a Columbus business culture that accepts Excellence as an expectation, compliance as an outcome and goal.

Provides coaching, and facilitation support to all levels at the Hypodermic BU Columbus plant.

Interfaces with Regulatory Agencies (FDA, ISO notified body, other foreign regulatory bodies).

Leads and supports customer audits, internal audits.

Recommends and implements necessary actions and programs to continually upgrade the Quality Management/Quality System/Quality Engineering capability of the Hypodermic BU.

Engage and deploy zero customer complaints program.

Support Hypodermic BU to meet: CPM, Financial goals, Waste target, CI project, Deliveries, Zero past due AIR/ CAPA, BBQ, 5S.

SUPERVISION

this position will supervise 11 associates

REQUIREMENTS

Bachelor of Science degree in Engineering or Science related field.

Minimum 7 years experience in quality, with a minimum of 3 years in the medical device industry

Experience with Process Control.

Experience with high volume manufacturing processes.

Experience in Lean/Six Sigma.

Experience managing and leading people.

Experience communicating with all levels of the organization.

Capable to manage under pressure and set priorities accordingly.

Full support to a 24/7 operation.

Relocation Assistance Available - Possible for ideal candidates

Benefits

Full

Required Knowledge, Skills, and Abilities: (Submission Summary)

1. Bachelor of Science degree in Engineering or Science related field.

2. Minimum 7 years experience in quality,

3. Minimum of 3 years in the medical device industry

4. Experience with Process Control

5. Experience with high volume manufacturing processes.

6. Experience managing and leading people.

7. Full support to a 24/7 operation.

8. Experience in Lean/Six Sigma.

9. Salary Expectation?

10. Must be a US Citizen or Green Card holder?

11. Complete Current Address