... Quality System. * Segregate nonconforming product and handle quarantined product and raw materials as applicable by site. * Generate rejection and deviation reports as directed by site. * Perform ...
... Quality System. * Segregate nonconforming product and handle quarantined product and raw materials as applicable by site. * Generate rejection and deviation reports as directed by site. * Perform ...
Competitive pay with biweekly direct deposit (W-2) * Hands-on experience supporting critical manufacturing and quality systems in a leading biotechnology environment * Collaborative, fast-paced, and ...
Quick apply
Competitive pay with biweekly direct deposit (W-2) * Hands-on experience supporting critical manufacturing and quality systems in a leading biotechnology environment * Collaborative, fast-paced, and ...
Responsible for conducting a comprehensive internal audit program and ensures that the Internal Audit system is effectively implemented. The incumbent must work closely with the QA Director in the ...
Officer, Compliance II
Barceloneta, PR · On-site
Responsible for conducting a comprehensive internal audit program and ensures that the Internal Audit system is effectively implemented. The incumbent must work closely with the QA Director in the ...
Officer, Compliance II
Barceloneta, PR · On-site
Responsible for conducting a comprehensive internal audit program and ensures that the Internal Audit system is effectively implemented. The incumbent must work closely with the QA Director in the ...
Quality Engineer II
Humacao, PR · On-site +1
$72K - $94K/yr
May act as a mentor to colleagues or may direct the work of other lower level professionals. The ... Makes improvements of processes, systems or products to enhance performance of the job area.
Quality Engineer II
Humacao, PR · On-site +1
$72K - $94K/yr
May act as a mentor to colleagues or may direct the work of other lower level professionals. The ... Makes improvements of processes, systems or products to enhance performance of the job area.
Quality Engineer II
Humacao, PR · On-site
$72K - $94K/yr
May act as a mentor to colleagues or may direct the work of other lower level professionals. The ... Makes improvements of processes, systems or products to enhance performance of the job area.
Quick apply
Quality Engineer II
Humacao, PR · On-site
$72K - $94K/yr
May act as a mentor to colleagues or may direct the work of other lower level professionals. The ... Makes improvements of processes, systems or products to enhance performance of the job area.
Competitive pay with biweekly direct deposit (W-2) * Hands-on experience supporting critical manufacturing and quality systems in a leading biotechnology environment * Collaborative, fast-paced, and ...
Quick apply
Competitive pay with biweekly direct deposit (W-2) * Hands-on experience supporting critical manufacturing and quality systems in a leading biotechnology environment * Collaborative, fast-paced, and ...
Sr Quality Engineer
Humacao, PR · On-site
$89K - $121K/yr
May act as a mentor to colleagues or may direct the work of other lower level professionals. The ... Makes improvements of processes, systems or products to enhance performance of the job area.
Sr Quality Engineer
Humacao, PR · On-site
$89K - $121K/yr
May act as a mentor to colleagues or may direct the work of other lower level professionals. The ... Makes improvements of processes, systems or products to enhance performance of the job area.
Sr Quality Engineer
Humacao, PR · On-site
$89K - $121K/yr
May act as a mentor to colleagues or may direct the work of other lower level professionals. The ... Makes improvements of processes, systems or products to enhance performance of the job area.
Quick apply
Sr Quality Engineer
Humacao, PR · On-site
$89K - $121K/yr
May act as a mentor to colleagues or may direct the work of other lower level professionals. The ... Makes improvements of processes, systems or products to enhance performance of the job area.
Quality Senior Engineer
Arecibo, PR · On-site
$80 - $100/hr
Provide direct support to daily operations--respond to line issues, contain defects, and drive ... systems, MS Office and Minitab. * - EHS practices, regulations, and procedures experience.
Quality Senior Engineer
Arecibo, PR · On-site
$80 - $100/hr
Provide direct support to daily operations--respond to line issues, contain defects, and drive ... systems, MS Office and Minitab. * - EHS practices, regulations, and procedures experience.
Quality Senior Engineer
Arecibo, PR · On-site
$76K - $103K/yr
... System), and continuous Improvements Initiatives on the Products/Components or Manufacturing ... Essential Functions:1. Provide direct support to daily operations--respond to line issues, contain ...
Quality Senior Engineer
Arecibo, PR · On-site
$76K - $103K/yr
... System), and continuous Improvements Initiatives on the Products/Components or Manufacturing ... Essential Functions:1. Provide direct support to daily operations--respond to line issues, contain ...
Senior Quality Engineer
Arecibo, PR · On-site
$76K - $103K/yr
... System), and continuous Improvements Initiatives on the Products/Components or Manufacturing ... Essential Functions: 1. Provide direct support to daily operations-respond to line issues, contain ...
Senior Quality Engineer
Arecibo, PR · On-site
$76K - $103K/yr
... System), and continuous Improvements Initiatives on the Products/Components or Manufacturing ... Essential Functions: 1. Provide direct support to daily operations-respond to line issues, contain ...
Senior Quality Engineer
Arecibo, PR · On-site
$76K - $103K/yr
Essential Functions: 1. Provide direct support to daily operations-respond to line issues, contain ... systems, MS Office and Minitab. • EHS practices, regulations, and procedures experience.
Senior Quality Engineer
Arecibo, PR · On-site
$76K - $103K/yr
Essential Functions: 1. Provide direct support to daily operations-respond to line issues, contain ... systems, MS Office and Minitab. • EHS practices, regulations, and procedures experience.
Customer Quality Engineer
Arecibo, PR · On-site
Supports and maintains the Quality Management System of the local unit. All aspects managed in line ... May work under direct supervision or independently. May instruct or coach junior colleagues.Ensure ...
Customer Quality Engineer
Arecibo, PR · On-site
Supports and maintains the Quality Management System of the local unit. All aspects managed in line ... May work under direct supervision or independently. May instruct or coach junior colleagues.Ensure ...
Sr Engineer - 35630
Juncos, PR · On-site
$102K - $140K/yr
Define system boundaries and identify direct/indirect impact systems. * Lead risk assessments (e.g ... Collaborate with Engineering, Validation, Quality Assurance (QA), Manufacturing, and Supply Chain ...
Sr Engineer - 35630
Juncos, PR · On-site
$102K - $140K/yr
Define system boundaries and identify direct/indirect impact systems. * Lead risk assessments (e.g ... Collaborate with Engineering, Validation, Quality Assurance (QA), Manufacturing, and Supply Chain ...
Sr Engineer - 35630
Juncos, PR · On-site
$101K - $139K/yr
Define system boundaries and identify direct/indirect impact systems. * Lead risk assessments (e.g ... Collaborate with Engineering, Validation, Quality Assurance (QA), Manufacturing, and Supply Chain ...
Sr Engineer - 35630
Juncos, PR · On-site
$101K - $139K/yr
Define system boundaries and identify direct/indirect impact systems. * Lead risk assessments (e.g ... Collaborate with Engineering, Validation, Quality Assurance (QA), Manufacturing, and Supply Chain ...
... EX System Testing Team. This role is critical to ensure the reliability, performance, and ... Recruits and supports development of direct staff members. Typically reports to MG2 or Director.
... EX System Testing Team. This role is critical to ensure the reliability, performance, and ... Recruits and supports development of direct staff members. Typically reports to MG2 or Director.
... EX System Testing Team. This role is critical to ensure the reliability, performance, and ... Recruits and supports development of direct staff members. Typically reports to MG2 or Director.
... EX System Testing Team. This role is critical to ensure the reliability, performance, and ... Recruits and supports development of direct staff members. Typically reports to MG2 or Director.
... EX System Testing Team. This role is critical to ensure the reliability, performance, and ... Recruits and supports development of direct staff members. Typically reports to MG2 or Director.
... EX System Testing Team. This role is critical to ensure the reliability, performance, and ... Recruits and supports development of direct staff members. Typically reports to MG2 or Director.
... EX System Testing Team. This role is critical to ensure the reliability, performance, and ... Recruits and supports development of direct staff members. Typically reports to MG2 or Director.
... EX System Testing Team. This role is critical to ensure the reliability, performance, and ... Recruits and supports development of direct staff members. Typically reports to MG2 or Director.
Director Quality Systems information
What is a director quality systems?
A Director of Quality Systems is a senior management professional responsible for overseeing the development, implementation, and maintenance of an organization's quality management systems. They ensure that products and processes comply with industry standards, regulatory requirements, and company policies. This role often involves leading teams, developing quality strategies, conducting audits, and driving continuous improvement initiatives across the organization. Directors of Quality Systems play a critical part in safeguarding product quality, customer satisfaction, and regulatory compliance.
What are the key skills and qualifications needed to thrive as a director quality systems?
To thrive as a Director of Quality Systems, you need deep expertise in quality management principles, regulatory compliance, process improvement, and typically a relevant degree such as in engineering or life sciences. Familiarity with quality management systems (QMS) like ISO 9001, FDA regulations, and proficiency with tools such as CAPA, risk management software, and internal audit systems is essential. Strong leadership, strategic thinking, and effective communication distinguish top performers in this role. These skills ensure the organization maintains high quality standards, meets regulatory requirements, and drives continuous improvement across all operations.
What are some common challenges faced by a director quality systems when implementing new compliance standards across an organization?
A Director of Quality Systems often encounters challenges such as resistance to change from staff, alignment of existing processes with new regulatory requirements, and ensuring consistent training across departments. Effective communication and cross-functional collaboration are key to overcoming these hurdles. The role typically involves working closely with leadership, operations, and regulatory teams to ensure that new standards are understood and integrated smoothly, minimizing disruptions while maintaining compliance.
What is the difference between Director Quality Systems vs Quality Manager?
| Aspect | Director Quality Systems | Quality Manager |
|---|---|---|
| Responsibilities | Oversees quality systems, compliance, and strategic quality initiatives across departments | Manages daily quality operations, audits, and team supervision |
| Certifications | ISO 9001 Lead Auditor, CQE, Six Sigma | ISO 9001 Lead Auditor, CQE, Six Sigma |
| Work Environment | Strategic planning, cross-departmental collaboration | Operational focus, team management |
| Industry Usage | Common in regulated industries like pharmaceuticals, medical devices | Widely used in manufacturing, production facilities |
The main difference between a Director Quality Systems and a Quality Manager lies in scope and strategic focus. The Director typically oversees the entire quality system, ensuring compliance and strategic alignment, while the Quality Manager handles daily quality operations and team supervision. Both roles often require similar certifications and work in regulated industries, but the Director's role is more strategic and cross-departmental.
What are the most commonly searched types of Quality Systems jobs in Puerto Rico?
The most popular types of Quality Systems jobs in Puerto Rico are:
What job categories do people searching Director Quality Systems jobs in Puerto Rico look for?
The top searched job categories for Director Quality Systems jobs in Puerto Rico are:
What cities in Puerto Rico are hiring for Director Quality Systems jobs?
Cities in Puerto Rico with the most Director Quality Systems job openings:
Quality Auditor
Cidra, PR
West Pharmaceutical Services •
Pharmaceutical and Medicine Manufacturing • 10K+ employees10,000+ employees
Full-time
PTO
Re-posted just now
Key responsibilities
Perform sampling, inspections, and testing of in-process and finished goods products per applicable procedures and AQL plans.
Review inspection records to ensure product conforms to specifications and proper documentation practices.
Segregate nonconforming product and handle quarantined product and raw materials as applicable by site.
West Pharmaceutical Services rating
8.5
Based on 32 frontline employees who took The Breakroom Quiz
13th of 122 rated packaging manufacturers
Job description
At West, we're a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West's indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?
There's no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.
We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.
#LI-MQ1
Job Summary
The role is essential in ensuring in-process and finished products meet customer specifications. This role provides total manufacturing quality inspection services including quality inspection, quality control, sampling inspection, documentation and record keeping. Adhering to Good Documentation Process (GDP) is essential to maintain all documentation necessary to ensure conformity to specifications and traceability of records.
#LI-MQ1
Shift
- 12-hour shift on 2, 2, 3 rotation.
Essential Duties and Responsibilities
- Perform sampling, inspections, and testing of in-process and finished goods products per applicable procedures and AQL plans, utilizing both visual means as well as calibrated test equipment to include laser micrometer, optical comparator and other equipment as applicable.
- Release acceptable in-process and finished goods product for further processing and/or shipping as applicable per site.
- Understand and follow applicable ISO standards requirements.
- Perform review of inspection records to assure product conforms to specifications and proper documentation practices.
- Retains sample of finished products and maintains all applicable documents to form batch records and ensures appropriate batch records disposition (i.e. filing, scanning etc.) as necessary.
- Print documents from Master Control, shopfloor or other software program and manages documents related to the Quality System.
- Segregate nonconforming product and handle quarantined product and raw materials as applicable by site.
- Generate rejection and deviation reports as directed by site.
- Perform trace back investigation of nonconforming raw material and product as directed by site.
- Promotes and supports a Lean environment.
- Conforms with and abides by all corporate and site-specific regulations, policies, work procedures, instruction, and all safety rules.
- Exhibits regular, reliable, punctual and predictable attendance.
- Other duties as assigned.
Education
- High school diploma or GED required.
- Associate degree in Science, Math, or related field preferred.
Work Experience
- No minimum required.
- 1+ year in a cGMP environment or related field preferred.
Preferred Knowledge, Skills and Abilities
- ANSI, AQL, ShopFloor experience preferred.
- Basic computer skills.
- Ability to speak, read, and write in English preferred.
Travel Requirements
None: No travel required
Physical Requirements
Medium-Exerting up to 50lb/22kg of force occasionally and/or up to 20lbs/9kg of force frequently, and/or up to 10lbs/4kgs of force constantly to move objects.
What We Offer
Generous Paid Time Off (PTO): Flexible vacation, personal, and holiday leave ensures employees can maintain a healthy work-life balance and recharge effectively.
Recognition & Rewards: Performance-based bonuses, service recognition, and employee appreciation initiatives celebrate dedication and impact.
Inclusive & Collaborative Culture: A global workforce that values diversity, equity, and inclusion-where all voices are heard and respected in a supportive environment.
Continuous Learning & Development: Opportunities for professional growth through training programs, tuition assistance, leadership development, and skill-certification initiatives.
Global Career Opportunities: With facilities across North America, Europe, and Asia-Pacific, employees have opportunities for international exposure and cross-functional collaboration.
Community Involvement: West encourages volunteerism through its West without Borders initiative and other charitable programs that make a difference in local communities.
West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening.
What West Pharmaceutical Services employees say
Pay
Benefits
Hours and flexibility
Workplace
Get the full story on Breakroom
About West Pharmaceutical Services
Sourced by ZipRecruiter
Industry
Pharmaceutical and medicine manufacturing
Company size
10,000+ Employees
Headquarters location
Exton, PA, US
Year founded
1923