Decontamination Tech 2

Hologic, Inc.; Marlborough (MA); On-site; USD 45,000 - 68,000; Full time

Job summary

Hologic, Inc. in Marlborough, MA is seeking a Manufacturing Supervisor to oversee decontamination, testing, and assembly in a regulated medical device environment. You will ensure compliance with GMP, ISO 13485, and FDA requirements while leading a cross-functional team.

The role requires a High School Diploma, a technical Electronics credential is preferred, and at least 3 years of manufacturing experience in regulated settings. Strong documentation and communication skills are essential.

Qualifications

• High School Diploma or equivalent required.
• Technical degree or trade certification in Electronics Technology or related discipline preferred.
• Equivalent combination of education and relevant work experience will be considered.

Responsibilities

• Operate decontamination equipment for returned products.
• Clean and decontaminate products using proper PPE.
• Inspect, test, rework, and assemble products and subassemblies.
• Communicate production priorities with cross-functional teams.
• Support process validations and continuous improvement initiatives.
• Maintain 6S workplace standards and clean, safe environment.
• Verify calibration status and equipment readiness.
• Perform routine and preventive maintenance on equipment.
• Complete GMP-compliant manufacturing records accurately.
• Work effectively in a team-based manufacturing setting.
• Operate in Clean Room environments when required.
• Follow safety, quality requirements and company policies.
• Support special projects and overtime as needed.

Skills

MS Office

ERP/MRP systems

Oracle

Agile

Documentation

Communication

Education

High School Diploma

Electronics certificate/Technical degree

Experience considered

Tools

Oscilloscopes

Multimeters

Calibrated equipment

Job description

Under general supervision, perform testing, inspection, rework, decontamination, and assembly activities in accordance with assembly drawings, schematics, work instructions, and quality procedures. The incumbent will operate within a regulated medical device manufacturing environment and maintain compliance with ISO 13485, FDA 21 CFR Part 820, GMP, and applicable regulatory requirements.

Essential Duties and Responsibilities

The incumbent may be asked to perform other function-related activities in addition to the responsibilities listed below as reasonably required by business needs.

• Operate equipment used in the decontamination process for all products returned to Hologic.


• Properly clean and decontaminate returned products using required personal protective equipment (PPE) while following established procedures and safety protocols.


• Inspect, test, rework, and assemble products and subassemblies as required.


• Communicate daily with cross-functional departments regarding production priorities, material disposition, and operational requirements.


• Support process validations and recommend continuous improvement initiatives across multiple departments.


• Adhere to 6S workplace organization standards and maintain a clean, safe, and organized work environment.


• Verify that calibrated equipment is within specification and suitable for use.


• Perform routine equipment maintenance and preventative maintenance activities as required.


• Accurately complete manufacturing documentation and records in accordance with GMP requirements.


• Work effectively in a team-based manufacturing environment.


• Operate within a controlled Clean Room environment when required.


• Understand and comply with all safety regulations, quality requirements, and company policies.


• Support special projects and departmental initiatives as assigned.


• Work overtime as needed to meet decontamination and production schedules.

Qualifications

Education

• High School Diploma or equivalent required.


• Technical Degree or Trade School certification in Electronics Technology or a related discipline preferred.


• Equivalent combination of education and relevant work experience will be considered.

Experience

• Minimum of three (3) years of manufacturing experience, including assembly, testing, inspection, and shipment of products preferred.


• Experience in a regulated medical device, biotechnology, pharmaceutical, or healthcare manufacturing environment preferred.

Skills and Competencies

• Proficient in Microsoft Office applications; experience with Oracle, Agile, or similar ERP/MRP systems preferred.


• Ability to use common manufacturing and testing tools including screwdrivers, wrenches, torque tools, crimpers, soldering irons, multimeters, and oscilloscopes.


• Ability to read and follow written procedures, work instructions, engineering drawings, and quality documentation.


• Working knowledge of GMP, ISO 13485, FDA Quality System Regulations, and medical device manufacturing practices preferred.


• Strong computer skills, including spreadsheet applications and electronic data entry systems.


• Effective verbal and written communication skills.


• Ability to work independently with minimal supervision while managing multiple priorities.


• Strong attention to detail and commitment to producing high-quality work.


• Demonstrated problem-solving and continuous improvement mindset.

Physical Requirements

• Ability to sit, stand, walk, bend, and lift materials throughout the workday.


• Ability to lift and move materials weighing up to 25 pounds.


• Ability to wear required PPE and work safely with decontamination equipment and materials.


• Ability to work in a Clean Room environment and adhere to gowning requirements when applicable.

Compensation and Benefits

The annualized base salary range for this role is$45,400to $68,100 This position is also eligible for an annual bonus. Final compensation will be determined based on factors include experience, skills, education, geographic location, business needs, and market conditions.

Equal Opportunity Employer

Hologic is proud to be an Equal Opportunity Employer inclusive of individuals with disabilities and protected veterans.

Marlborough, MA, United States, US, MA Employee

Manufacturing Supervisor Why Hologic? At Hologic, our purpose is to enable healthier lives everywhere, every day. We are driven by our passion to become global champions for women's health and are committed to bringing ...