Supervisor, Manufacturing Operations

Integra LifeSciences; Mansfield (MA); On-site; USD 67,650 - 112,700; Full time

Job summary

Integra LifeSciences in Mansfield, MA seeks a Supervisor, Manufacturing Operations to lead daily production in Machining, Packaging and Boxing while ensuring safety, quality and efficiency across shifts.

The role requires 3+ years of GMP leadership, strong regulatory knowledge and experience with cleanroom gowning. You will drive Lean initiatives, mentor staff and collaborate with QA and Materials Management to optimize throughput.

Qualifications

• Bachelor's degree or higher in Science, Engineering, or related field.
• 3+ years of leadership experience in a GMP regulated environment.
• Knowledge of NCs and CAPAs.
• Strong written and verbal communication; leadership and team-focused.
• Ability to gown into ISO 7 and ISO 5 clean room.
• Batch manufacturing experience.
• Familiarity with FDA, ISO 9001/13485 and related regs.
• Strong computer skills, MS Office.
• Automation experience preferred.
• Oracle R12/Agile knowledge.
• Lean/Six Sigma knowledge a plus.

Responsibilities

• Direct daily production activities and staff in Machining, Packaging, Boxing areas for multiple product lines.
• Meet daily production goals and report progress at shift and tier meetings.
• Operate, maintain, troubleshoot process equipment and make minor adjustments as needed.
• Maintain logs, inventories and place purchase requisitions for processing supplies.
• Lead operations in cleanroom environment with proper environmental controls.
• Support Non-Conformance/CAPA/Audit investigations.
• Ensure compliance with GMP standards and SOPs.
• Lead process improvements and Lean initiatives to boost performance.
• Collaborate with cross-functional teams and mentor staff.
• Perform admin tasks like timecards and training records.
• Interface with QA for inspections and with Materials Management for material flow.
• Promote safety and continuous improvement within the department.
• Work with Manufacturing Engineering to improve yield and reduce scrap.

Skills

Leadership

Communication

GMP

Lean Six Sigma

ISO 9001

Regulatory compliance

Education

Bachelor’s degree or higher in Science/Engineering

Tools

Oracle R12/Agile

Microsoft Office

Job description

Changing lives. Building Careers.

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

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.

Summary

This position 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. 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.

Job Description

• Responsible for directing the daily production activities and staff in the Machining, Packaging, Boxing areas in support of multiple product lines.
• Ensure daily production goals are met and report production line progress at shift and tier meetings.
• Ability to operate, maintain, troubleshoot process equipment, and make minor adjustments as needed. Escalate issues that cannot be triaged or resolved.
• Accurately maintain 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. Place Purchase Requisitions for general processing supplies.
• Leads operations in cleanroom environment and assurances proper environmental controls and behaviors of team.
• Support any Non-Conformance/CAPA/Audit related investigations.
• Responsible for maintaining legible and accurate records and other procedures to comply with regulatory requirements, Good Manufacturing Practices (Quality Systems Regulations) and Standard Operating Procedures.
• Plan and lead manufacturing process improvements, and other Lean initiatives to optimize performance and drive short-term and long-term business improvements.
• Support and participate in cross-functional teams.
• Coach, counsel, train and motivate staff— provide clear direction and oversight of staff in effectively carrying out their daily responsibilities.
• Perform administrative duties (e.g. review and approve timecards, overtime, absenteeism reports, place purchase requisitions, maintain training records, etc.)
• Maintain a clean and orderly work area and perform all work in compliance with Good Manufacturing Practices (Quality Systems Regulations), and Standard Operating Procedures, and Health and Safety requirements.
• Interface with QA department during 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.
• Demonstrate safe behavior and support department/plant Safety goals in a continuous improvement process.
• Perform other related duties as expected.
• Works with Manufacturing Engineering and Product Development to improve yield and reduce scrap.

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.
• Must have strong written and verbal communication skills. Must possess 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.
• Automation experience a preferred.
• Knowledge of Oracle R12/Agile preferred.
• Understanding of Lean/six Sigma a plus.

Salary Pay Range

$81,650.00 - $112,700.00 USD Salary

Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training.

In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation.

Addtional Description for Pay Transparency

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards | Integra LifeSciences

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:

EEO Is the Law | EOE including Disability/Protected Veterans

Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at [e-mail].