Quality Regulatory Manager Jobs in Puerto Rico (NOW HIRING)

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The Senior Manager, Value Stream Leader is responsible for end-to-end performance of a Tissue Technology medical device production value stream platform. Work includes acceptance of design transfers, through lifecycle management to final device shipment. They are responsible for implementing strategies and plans to meet short and long-term goals to achieve the highest standards of safety, quality, customer service, and productivity. They are responsible for all aspects of safety and security, manufacturing, engineering, quality, regulatory, and project management within the value stream as measured by safety, quality, delivery, and cost key performance indicators (KPI's). They ensure the production of medical products is in compliance with corporate policies, U.S. Food and Drug Administration regulations, ISO 9001, ISO 13485, EU MDR, the Canadian Medical Device Regulations (CMDR), and other applicable regulatory agencies.
REPORTING & MANAGEMENT SCOPE SUPERVISION RECEIVED
Under direct supervision of the Plant Manager
SUPERVISION EXERCISED
Position will directly manage operations technicians, operators, managers, supervisors, and process engineers.
KEY RESPONSIBILITIES

• Ensures the safety of colleagues through effective and continuously improving environmental, health, and safety program engagement. Ensure all team members receive training, and are knowledgeable and compliant regarding safety procedures, policies, permits, practices, PPE, proper housekeeping, and awareness. Initiates and lead accident, near miss, and incident event notifications.
• Lead, coach, and develop a team of technicians, operators, managers, supervisors, and process engineers.
• Responsible for managing staffing, training and daily maintenance operations across shifts up to 7 days a week, including attendance, overtime, operational issues, talent management, performance management, development planning and reporting of results. Interviews job candidates, completes performance reviews, and justifies promotions or disciplinary actions (as appropriate).
• Serve as a member of the site leadership team participating in strategic and tactical planning & execution to ensure site objectives are met. Ensure alignment of value stream objectives with overall site objectives.
• Foster a culture of colleague engagement thru positive leadership, recognition, accountability, feedback, continuous improvement, and engagement activities • Responsible for the team's compliance and meeting the quality standards as defined by Integra's SOPs, GMPs, Global Quality Standards, local and procedures, where applicable. Partner with Quality Assurance and Regulatory Affairs to ensure full compliance with applicable standards (FDA QSR, GMP, ISO 13485, etc).
• Initiate, develop and implement engineering studies and IQ/OQ/PQ/TMV validations for equipment and processes to meet the demands of new product introductions and current manufacturing operations. Coordinate specific efforts as required by the project team. Includes such tasks as development of manufacturing process requirements, specifications, Failure Mode Effects Analysis (FMEA), validations, Engineering Change Requests/Orders (ECR/ECO) and Engineering Drawings.
• Ensures investigations/CAPAs/nonconformances identify root cause, are appropriately corrected with sustainable remediations. Leverage data/tools/techniques to identify root causes and implement sustainable corrective actions. • Ensure training and process documentation requirements are consistently met. • Partner with supplier quality and procurement to ensure supplier issues and changes are addressed appropriately within quality management system in a timely manner.
• Coach/mentor lean six-sigma manufacturing initiatives (5S, Kaizen, Value Stream Mapping, Kanban, Standard Work. OEE) to reduce waste and improve flow across the value stream.
• Ensure teams deliver measurable improvements in yield, throughput, and cycle time across the value streams in line with KPI targets.
• Partner with the cross-functional teams to meet customer fulfillment needs as well as lead process optimization, yield improvement, six sigma process excellence and lean projects. Monitor process capability and performance metrics (CoPQ, Cpk, yield, run time, downtime, scrap). Develop process/project improvement and mitigation projects to improve capability and performance.
• Develops, reviews, approves, and accountable for all financial budgets within the value stream, including headcount, expense, capital, and inventory.
• Ensure value stream cost of goods sold (COGS) results are in line with financial targets by ensuring bill-of-materials (BOMS), routers, and process instructions align to costs. • Work cross-functionally and collaboratively to solve operational issues. Interacts with senior management on matters concerning several job areas, departments, and/or customers to accept new concepts, practices and approaches as well as with senior level vendors or customer representatives concerning projects & operational decisions.
• Complete other job-related duties as assigned.

SKILLS & COMPETENCIES

• Engineering or Technical degree with 8+ years of experience leading a team (direct reports or projects) or equivalent education and years of management experience OR master's degree with 5+ years of experience leading a team (direct reports or projects) or equivalent education and years of management experience
• Demonstrate excellent organizational and English communication skills (oral & written)
• Financial acumen relating to operations profit & loss (P&L) items
• Proficiency in MS Office Suite and statistical analysis software.
• Experience in regulated environment; medical device or pharma preferred
• Familiarity with health, safety, and environmental regulations related to manufacturing.
• Experience in regulated environment; medical device or pharma preferred
• Self-motivated team player with ability to work independently and collaboratively across all levels of the organization. TOOLS AND EQUIPMENT USED This role requires regular use of tools and equipment relevant to the work environment. Examples include:
• General office equipment: Computers, printers, copiers, fax machines, and telephone communication systems.
• Software and systems: ERP systems (e.g., Oracle), CRM platforms, statistical analysis tools, project management software (e.g., MS Project, Jira), QMS platforms.

PHYSICAL REQUIREMENTS
The physical requirements listed below represent the motor and physical abilities necessary to successfully perform the essential duties of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to enable individuals with disabilities to perform these duties. While performing the responsibilities of this role, the employee is expected to:

• Sit, listen, speak, and move throughout various areas of the building.
• Travel across all company locations as needed.
• Periodically lift and/or move items up to twenty-five pounds.
• Travel domestically and internationally via car, train, or airplane, as required by the role.

ADVERSE WORKING CONDITIONS
The conditions listed below represent environmental factors which the employee may be exposed to while performing the essential duties of this position. These reflect a general plant or service environment. Adverse exposure may include handling hazardous and biohazardous materials such as:

• Flammable and corrosive liquids
• Compressed gases
• Medical waste
• Appropriate safety protocols and personal protective equipment (PPE) are required and provided.

Salary Pay Range:
$87,000.00 - $122,000.00 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 trainingIn addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensationYour recruiter can share more about the specific salary range for your preferred location during the hiring process.
Additional 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.
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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 careers@integralife.com.
Unsolicited Agency Submission
Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate's name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.
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