Supervisor, Manufacturing Operations

Integra LifeSciences•Mansfield, MA

4d•$81,650 - $112,700•Onsite

About The Position

This Supervisor, Manufacturing Operations will lead and direct all activities in the manufacturing area at Integra's Mansfield, MA manufacturing facility. This site manufactures medical devices primarily used in Neurosurgical applications. The Supervisor, Manufacturing Operations is responsible for supervising production personnel to maximize safety, quality, delivery, cost and engagement metrics in the manufacturing operation. Accountable for achieving production targets while maintaining cost controls.

Requirements

Bachelor’s degree or higher in Science, Engineering, or related fields is desired or equivalent combination of education and relevant leadership experience in a regulated environment will be considered.
3+ years of relevant leadership experience in a GMP regulated industry.
Knowledge of NCs and CAPAs.
Strong written and verbal communication skills.
Strong leadership skills with team-focused attitude and approach.
Must be able to gown into ISO 7 and ISO 5 Clean Room gowning.
Batch manufacturing experience.
Demonstrated knowledge of FDA regulations, ISO 9001, ISO 13485, and other National and International regulations and standards.
Strong computer skills, including Microsoft Office experience required.

Nice To Haves

Automation experience a preferred.
Knowledge of Oracle R12/Agile preferred.
Understanding of Lean/six Sigma a plus.

Responsibilities

Directing the daily production activities and staff in the Machining, Packaging, Boxing areas in support of multiple product lines.
Ensuring daily production goals are met and reporting production line progress at shift and tier meetings.
Operating, maintaining, and troubleshooting process equipment, and making minor adjustments as needed. Escalating issues that cannot be triaged or resolved.
Accurately maintaining all entries into all required logs, log books and records pertaining to Machining, Packaging, Boxing and other work-in-progress related (WIP) activities. Responsible for maintaining process and component inventories. Placing Purchase Requisitions for general processing supplies.
Leading operations in a cleanroom environment and assuring proper environmental controls and behaviors of the team.
Supporting any Non-Conformance/CAPA/Audit related investigations.
Maintaining legible and accurate records and other procedures to comply with regulatory requirements, Good Manufacturing Practices (Quality Systems Regulations) and Standard Operating Procedures.
Planning and leading manufacturing process improvements, and other Lean initiatives to optimize performance and drive short-term and long-term business improvements.
Supporting and participating in cross-functional teams.
Coaching, counseling, training and motivating staff— providing clear direction and oversight of staff in effectively carrying out their daily responsibilities.
Performing administrative duties (e.g. reviewing and approving timecards, overtime, absenteeism reports, placing purchase requisitions, maintaining training records, etc.).
Maintaining a clean and orderly work area and performing all work in compliance with Good Manufacturing Practices (Quality Systems Regulations), and Standard Operating Procedures, and Health and Safety requirements.
Interfacing with the QA department during the normal course of work to coordinate inspections of completed product and to interface with the Materials Management Department to ensure efficient flow of materials through operations.
Demonstrating safe behavior and supporting department/plant Safety goals in a continuous improvement process.
Performing other related duties as expected.
Working with Manufacturing Engineering and Product Development to improve yield and reduce scrap.