Limiting Uncertainty For The Busiest Surgeons
Assembly SupervisorBoston, MA
Integra LifeSciences is a global leader in regenerative technologies and neurosurgical solutions dedicated to limiting uncertainty for clinicians, so they can focus on providing the best patient care.
Founded in 1989, Integra develops, manufactures, sells and supplies best-in-class products to regenerate tissue, remove brain tumors, prevent infection and much more. And over the last three decades, we’ve evolved into one of the world’s leading global medical technology companies with more than 4,000 dedicated employees who deliver innovative medical technology solutions.
But that’s just the beginning. Integra is growing at an unprecedented rate. We’re at a moment in time where the experience you’ll gain is more robust than the experience you bring. And we’re out to invest in your future because it’s the best way to maximize ours.
At Integra, we firmly believe our people are our greatest asset and the foundation of our success. Our comprehensive Global Total Rewards program provides competitive compensation and benefits designed to keep our people healthy, motivated and engaged. Investing in our people through these programs is possible because of Integra’s ongoing commitment to our values and our shared success.
Integra’s health as a company begins with the well-being of our people. Benefit programs vary by country, whether provided through company-sponsored insurance and programs, through statutory government programs, or a combination of both.
Regardless of geographic location, our commitment is to offer the following, whenever possible:
• Benefit plans that meet all local statutory requirements
• A range of programs that reflect typical local market practices
• An opportunity for employees to tailor benefits to their specific needs
• Benefits that balance employee’s short-term and long-term needs
Reports to the Production Manager
This position has direct supervisory responsibilities of Device process Operators
ESSENTIAL DUTIES AND RESPONSIBILITIES
• Supervise Device Process Operators.
• Use department databases to track and manage scheduled Device production.
• Effectively follow SOPs, policies, and ISO/QSR inventory requirement.
• Provides direction and Guidance to intermediate and entry level Process Operators.
• Communicate technical details of production schedule to manufacturing personnel.
• Assist in updating SOPs as necessary.
• Manage Production inventory levels.
• Develop business continuity/resilience plan and methodically eliminate high risk single points of failure: people, equipment, suppliers.
• Provide support to the Quality Team during corporate audits.
• Actively participate in department activities and confirm compliance with controlled procedures are required.
• Attend all scheduled production meetings.
• Reports on all resource issues such as personnel, material, and equipment.
• Review & transact DHR Batch Records in MAS200 and Oracle system as needed.
DESIRED MINIMUM QUALIFICATIONS
• Education: An Associates/Bachelor’s Degree or equivalent with related work experience is required.
• Experience: A minimum of 2-5 years’ supervisory experience in medical device, pharmaceuticals, Quality/Regulatory Compliance, or other regulated product preferred environment.
• Familiarity with application of FDA and/or ISO quality standard in a government regulated industry.
• Experience working in an ISO certified cleanroom and gowning requirements Capable of supervising 15-17 direct reports while performing their own duties.
• Moderate computer competence, including experience with database and Microsoft Office software to create reports, spreadsheets, analyze date and prepare presentations.
• Ability to follow instruction precisely, recognize deviation, and recommend corrective action.
• Excellent communication and organizational skills, Strong in interpersonal skills and ability to work with others in a positive and collaborative manner.
• Experience with Oracle and MAS200 preferred.
TOOLS AND EQUIPMENT USED
This role routinely uses standard office equipment (i.e., computers, phones, photocopiers, filling cabinets, fax machines, as well as other general office equipment). Computer skill including demonstrated proficiency with computer office application software
The physical requirements listed in this section include, but are not limited, to the motor/physical abilities and skills require of position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position.
While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen. Speak and have the ability to move throughout all location of the building. The employee is required to go to all areas of the company. The employee may be required to periodically lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vison, Color vison, Peripheral vison, depth perception and ability to adjust focus. Ability to travel via car, train and/or airplane to domestic and international location as needed.
ADVERSE WORKING CONDITIONS
The adverse working conditions listed in this section include, but are not limited to, those environmental conditions to which the employee may be exposed while undertaking the essential duties and responsibilities of this position.
Adverse exposure may result form the handling of hazardous and bio-hazardous material the include, but not limited to, flammable and corrosive liquids, compressed gases, sharps, and medical wastes.