Project Quality Sr Engineer

About Convatec
Pioneering trusted medical solutions to improve the lives we touch:
Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in Advanced Wound Care, Ostomy Care, Continence Care, and Infusion Care. With more than 10,000 colleagues, we provide our products and services in around 90 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Convatec's revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit

As a Sr Engineer, Quality Project you will assure the good environment of quality engineering team is established.

Maintain trained and motivated personnel in the areas to her/his responsibility.

Main leader assuring the compliance for regulations, standards, QMS internal procedures on a New Project (CCR)

Process Improvements (OFI), Validation & Revalidations, Risk Management, Customer complaints investigations which are direct handled by his team - Projects Quality Engineer (PQE).

Assure that quality issues are well handled from a non-conformity, maintain quality indicators and internal deviations ensuring the activities are taken in a proper manner and time.

Main responsibilities:

Supervise the activities of personnel under his/her responsibility.

Evaluate the necessary resources to perform the tasks on respective areas. Identify needs and perform training in the areas for personnel in charge. Develop the personnel's skills under his/her responsibility.

Keep communication with other areas in relation to quality problems or improvements (production, maintenance, engineering, logistics, suppliers etc.). Promote ideas for continuously improvements of Quality with the end achieve the fulfillment across of the systems simplicity.

Follow up on NC's/PPMs trending as well as VPM

Assure quality monthly report

Review and approve quality specifications documents. Onlines, etc.

Process Control related

Oversee and coordination on the investigation related to Process Failures, Customer Complaints, Other quality issues through his resources.

To make sure that NC process/activities are followed adequately and under applicable procedure.

Review objective evidence to complete investigations and therefore assure correct NC closure and effectiveness.

Issue and NC/CAPA when needed according to procedures established. Participate on Review Board meetings.

Make sure final dispositions are well documented and following the proper procedures.

Support the quality system by being focus on adequate handling of non-conformity activities, corrective and preventive actions.

Support to define a classification of all Non-Conformities based upon the risk. Review, update and develop procedures, instructions, quality specification as needed.

Follow up the QA roll as per NC procedure require (for instance, Originator, Owner, Quality Reviewer, Approver, etc.) as needed.

Support at several areas where his/her experience and technical knowledge about the problem can be usefully (production, microbiology, systems, etc). Lead and keep communication with other departments MX / DK in relation to any quality problem.

Overall participation in projects as main responsibility through the PQEs assuring that regulations or other applicable standards are met.

Support on the risk management system, when is needed.

In cooperation with the Engineering department ensure resource and planning for revalidation activities is well handled.

Assure the Filling of validation documentation is following procedures and applicable regulations through the PQE in charge.

Support on review and approval in IQ, OQ and PQ validations as well in PSE in all systems applied, in collaboration with project leader

Support on review and approval in the management of software validations / test equipment and method validation.

Collaborate on validation of molds and molding machines providing the support as Quality Engineering, when is needed.

To comply with the company quality policy.

Qualification & Education

Bachelor's degree (Mechanical, Electronic, Industrial area or similar education) required

Min. 3 Years' Experience On Engineering Areas, Required
Verbal and written English, required

Strong Experience on handling of QMS (Quality management system), required Strong Experience on Quality Control Charts (histogram, pareto, process capability calculations, controls charts, etc), required

Strong Experience on Quality Management Tools (brainstorms, flow diagrams, cause and effect diagrams, etc.) required

Focus on continues improvement mindset, required

Strong to capture, describe and communicate ideas to the teamwork, preferred Auditor skills, preferred

Supervisor Experience, Preferred
Training/Knowledge on MDSAP, MDR, FDA QSR's and GMP's, ISO 13485, J-PAL/Ordinance No.169, EU and Canadian medical devices regulation, or similar regulations, preferred

Familiar with common computers software packages. MS Office, Lotus Notes, etc. required

What you'll
g
et:

• Competitive salary + bonus
• Training & development
• Collaborative, supportive culture

Ready to join us?
At Convatec, we're pioneering trusted medical solutions to improve the lives we touch. If you're ready to make a real impact, apply today and help us bring our Forever Caring promise to life.

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A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.

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Equal opportunities
Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.

Notice to Agency and Search Firm Representatives
Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Already a Convatec employee?
If you are an active employee at Convatec, please do not apply here. Go to the Career Worklet on your Workday home page and View "Convatec Internal Career Site - Find Jobs". Thank you