- Align North American process and reporting standards to accurately document nonconformances, CAPAs, and associated corrective actions in accordance with regulatory guidelines.
- Oversee, collect and analyze quality data, and report on North America site external and internal audit observations and corrective action status.
- Collaborate with all lines of businesses as assigned to conduct investigations into product quality issues, deviations, out-of-specification events, and nonconformances, ensuring prompt and effective resolution.
- Develop training and tools to empower employees to utilize root cause analysis methodologies (6M, Fishbone, 5 Whys, etc.) to identify underlying factors contributing to nonconformances.
- Develop and implement corrective and preventive actions (CAPAs) to address identified root causes and prevent recurrence of nonconformances. Ensure that CAPAs are well-defined, executed in a timely manner, and effectively tracked to completion.
- Prepare and present reports summarizing investigation findings, root causes, corrective actions, and outcomes to management and relevant stakeholders.
- Collaborate with cross-functional teams, including Quality, Regulatory, Operations, R&D, etc .to implement process improvements based on analysis from nonconformance investigations.
- Monitor the effectiveness of implemented corrective actions, measuring key performance indicators to evaluate progress and drive continuous improvement.
- Stay up-to-date with relevant quality standards, regulatory requirements, and industry best practices related to nonconformance and CAPA processes.
- Responsible for oversight and reporting on quality data in other quality system processes, as assigned.
- Bachelor's Degree in Life Sciences or technical discipline (chemistry, biology, etc.) or related field
- Minimum four years of experience in regulated industry
- Minimum two years of direct experience in nonconformance and CAPA investigation
- Prior experience supporting and hosting regulatory inspections
- Certified quality auditor or similar industry certification preferred
- Effectively negotiates and builds partnerships throughout multiple organizational levels of business
- Confident in resolving ambiguity, assessing and interpreting regulation, and leading ad hoc teams through compliance improvement and change
- Experience working in regulated industry (pharmaceutical, compounding, medical device, etc)
- Strong data management skills
- Detail-oriented with strong analytical skills
- Excellent verbal and written communication skills
- Ability to work independently and be self-motivated
- Pet friendly environment
- Extensive computer work
- Business travel (up to 15%)
-
System engineer
3 weeks ago
BlueWave Solutions Freeport, United StatesAre you interested in a new professional position as an engineer at Freeport? · Piening is one of the top engineering and IT service providers in Germany. With over 90 locations throughout the country, we ensure every day that our employees and clients can grow both professionall ...
-
Electrical Engineer Embedded Systems
3 weeks ago
Titan Ventures Raymond, United StatesYour Responsibilities · You will be responsible for creating and evaluating system, software, and hardware architectures for electronic components and systems in building system technology. · You will capture and describe functional and non-functional requirements and coordinate ...
-
Senior Power System Protection Engineer
1 week ago
Burns & McDonnell Portland, United StatesResponsible for leading or executing power system protection and control engineering projects. Projects range in size, complexity, and voltage class from small distribution equipment upgrades to large transmission projects. This position can influence the future of the resiliency ...
-
Senior Power System Protection Engineer
3 weeks ago
Infra-Rec Portland, United StatesLead or execute power system protection and control engineering projects of various sizes and complexities.Design relay settings for high voltage electrical substations (13kV-500kV).Coordinate and lead project activities, individually and within teams.Execute complex assignments, ...
-
Senior Power System Protection Engineer
1 week ago
Burns & McDonnell Portland, United StatesResponsible for leading or executing power system protection and control engineering projects. Projects range in size, complexity, and voltage class from small distribution equipment upgrades to large transmission projects. This position can influence the future of the resiliency ...
-
Senior Power System Protection Engineer
2 weeks ago
Burns & McDonnell Portland, United StatesResponsible for leading or executing power system protection and control engineering projects. Projects range in size, complexity, and voltage class from small distribution equipment upgrades to large transmission projects. This position can influence the future of the resiliency ...
-
Senior Power System Protection Engineer
3 weeks ago
Infra Rec Portland, United StatesLead or execute power system protection and control engineering projects of various sizes and complexities. · Design relay settings for high voltage electrical substations (13kV-500kV). · Coordinate and lead project activities, individually and within teams. · Execute complex ass ...
-
Sr z/OS Systems Engineer
3 weeks ago
Workday Portland, United StatesOur Fortune 500 company is driving a digital transformation and looking for forward-thinking innovators to disrupt how our industry thinks about and uses technology. As one of the world's leading employee benefits providers, we help millions of people gain affordable access to be ...
-
Mainframe Core Banking System Engineer
3 weeks ago
ZephyrTech Hunnewell, United StatesWe are the digitalization partner of the cooperative financial group and combine decades of banking expertise with modern information technology. Our IT solutions and services, specifically tailored to banks, range from data center operations to the banking system agree21 to app ...
-
Quality Systems Engineer
3 weeks ago
GTT, LLC Westbrook, ME, United States TemporaryQuality Engineer · Contract Duration 3 Months · Manufacturing Line Quality Engineers operate as an independent Quality resource partnered with Production to facilitate GMP, GDP, and Client quality standard compliance. · Quality Engineer is responsible for assisting in the impl ...
-
Assistant Project Manager
2 weeks ago
Electrical Consultants, Inc. Cumberland, United StatesElectrical Consultants, Inc. (ECI) is a leading power engineering consultant firm that provides engineering, system planning and studies, technical consultation, project management, surveying, environmental planning, commissioning/testing and construction services to electric uti ...
-
Substation Project Manager
3 weeks ago
Electrical Consultants, Inc. Cumberland, United States**Locations**:Cumberland, ME; Waterville, ME; Augusta, ME; Manchester, NH; Ayers, MA; Berlin, CT · **Description**: Electrical Consultants, Inc. (ECI) is a leading power engineering consultant firm that provides engineering, system planning and studies, technical consultation, pr ...
-
Engineering Technician
2 weeks ago
Nichols Portland, LLC South Portland, United States**Position Summary**: · This high-level engineering technician role utilizes education, experience, and abilities to support the validation and launch of product designs as either part of an independent assignment or as part of a larger project team. This is a second shift positi ...
-
Vp of Inventory and Procurement
1 week ago
Biotouch Cumberland, United States**Responsibilities**: · - Overseeing and directing sourcing and strategy personnel. Lead all procurement functions for a multisite domestic assembly and distribution facilities with hands on oversight of sourcing/procurement, · - Establishing communication and relationships with ...
-
Quality Systems Engineer
3 weeks ago
GTT, LLC Scarborough, ME, United States TemporaryQuality Engineer · Contract Duration 3 Months · Manufacturing Line Quality Engineers operate as an independent Quality resource partnered with Production to facilitate GMP, GDP, and Client quality standard compliance. · Responsible for assisting in the implementation and maint ...
-
Lead Automation Tester
3 weeks ago
Crosslake Technologies Poland, United StatesHow we serve clients · - Companies often struggle to get the results from technology that we know are possible. Well-implemented technology can be world changing. It removes waste and makes us better at what we do. · - Our mission is to help others achieve the true benefit that t ...
-
Automation Tester
3 weeks ago
Crosslake Technologies Poland, United States**How we serve clients** · - Companies often struggle to get the results from technology that we know are possible. Well-implemented technology can be world changing. It removes waste and makes us better at what we do. · - Our mission is to help others achieve the true benefit th ...
-
Diesel Technician
1 week ago
Love's Travel Stops & Country Stores Cumberland, United States**Req ID**: 436689 · **Address**: 13300 Ali Ghan Road Cumberland, MD, 21502 · **Benefits**: · - Paid Time Off · - Flexible Scheduling · - 401(k) - 100% match up to 5% · - Medical/Dental/Vision Insurance after 30 days · - Competitive Pay · - Career Development * · Welcome to Love' ...
-
Facilities Working Foreman
3 weeks ago
Town of Falmouth, MA Falmouth, United States**Location**: · - Facilities Maintenance, Falmouth, MA 02540 · **Department**: · - BLDG FAC MAINT · **Division**: · - None · **Job Status**: · - Full-Time · **Shift**: · - 6:00 AM - 2:30 PM · **Days**: · - Mon., Tue., Wed., Thu., Fri. · **Hours Per Week**: · - 40 · The Town of Fa ...
-
Infinity Systems Freeport, United StatesYour future. What to expect · Ensuring smooth and highly available operation of our centrally managed hybrid Microsoft Exchange environment as well as the company-wide Microsoft Active Directory including its associated central subsystems · Provision and operation of Exchange ser ...
Quality Systems Engineer - Portland, United States - Covetrus
Description
SUMMARY
The Quality Engineer is an experienced quality system professional that ensures assigned quality system processes are implemented, maintained, monitored, and reported on to ensure adequacy and continuous improvement. This role will primarily focus on nonconformance and CAPA quality systems, leading and supporting investigation, root cause analysis, corrective actions, and nonconformance and CAPA processes for our North American operations including analytical testing laboratory. The ideal candidate will have a strong background in quality engineering, problem-solving skills, and a commitment to maintaining quality standards.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
QUALIFICATIONS:
EDUCATION AND/OR EXPERIENCE
CERTIFICATES, LICENSES, REGISTRATIONS
COMPETENCIES (SKILLS AND ABILITIES)
PHYSICIAL DEMANDS/WORK ENVIRONMENT
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Covetrus is an equal opportunity/affirmative action employer. It does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated with undue hardship, sex, sexual orientation, age, citizenship, marital or veteran status, or any other legally protected status.
We offer the following benefits for you to take advantage of while you are here provided you meet the eligibility requirements under each governing program:
* 401k savings & company match
* Paid time off
* Paid holidays
* Maternity leave
* Parental leave
* Military leave
* Other leaves of absence
* Health, dental, and vision benefits
* Health savings accounts
* Flexible spending accounts
* Life & disability benefits
* Identity theft protection
* Pet insurance
* Sales Positions are eligible for a Variable Incentive
* Certain positions may include eligibility for a short term incentive plan
Covetrus is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
