Job Description
Imagine working for one of the leading contract manufacturers in the world. Trelleborg Medical Solutions is located 30 miles from California’s pristine Central Coast. As a premier manufacturer for life-saving medical components, Trelleborg Medical Solutions is a forward-thinking company. We have been active in our lean manufacturing journey for many years and are advancing towards making our business a showcase of excellence in the medical industry.
Seize this rare opportunity to be part of a healthcare and medical business unit that has been in business for over 100 years, all while enjoying the benefits of living in one of California’s most desired locations!
As a valued Trelleborg team member, you will enjoy:
- Greater opportunity for impact;
- Competitive compensation;
- Outstanding benefits package: Health, Dental, Vision, STD, LTD, Life, 401k;
- Generous paid time off;
- Bonus potential
Trelleborg Medical Solutions is seeking a Document Control Specialist. In this role, you will be responsible for maintaining and administering document control processes to support quality, regulatory, and business requirements. This role manages controlled documents and records, facilitates document and change control activities, supports cross-functional teams, and assists with audits and quality system activities to ensure compliance, accuracy, and accessibility of documentation throughout the organization.
Tasks and Responsibilities
- Effectively follows standard operating procedures, policies, and regulations.
- Support day to day requirements of the documentation system
-
- Maintains all controlled and other Quality System documents
-
- Creates, updates, publishes and distributes documents. Initiates requests to make changes that include formatting, printing, and distribution of SOPs, WIs, forms, etc.
-
- Supports and assists all departments through document change control process. Manages release and control of updates to the Quality System and archival of obsoleted documents.
-
- Ensures that documents are released in a reasonable time period and follows up with responsible parties and reassigns, as needed
-
- Ensures that timely access to the latest revision level documentation is available to all appropriate users and ensures that obsolete documentation is removed from distribution
- Creates and maintains a variety of logs, as necessary. Assigns numbers when requested and supports departments in processing of the documentation.
- Manages all records in an organized manner to ensure records are easily identifiable and accessible.
- Reviews Quality records for accuracy and mistakes, identifies errors and escalates as needed.
- Scans and verifies that scanned records are accurate and legible compared to the original.
- Supports audit activities.
- Participates in company internal audits.
- Provides support for the Quality System during external audits by Trelleborg Sealing Solutions’ customers, notified body or regulatory agencies.
- Supports Complaint, CAPA, LIR, and etc investigation activities, as needed.
Education and Experience:
Required:
- High School Diploma or equivalent
- 2 years of Document Control experience
Desired:
- Quality certifications (ASQ CQT, CQI, etc.)
- Knowledge and experience with GMP/ISO Standards
Competencies:
- Ability to read, write, speak and understand the English language
- Ability to communicate clearly by conveying and receiving ideas, information and direction effectively
- Ability to demonstrate adequate job knowledge to deliver a world class performance
- Ability to challenge oneself to consistently meet all goals and deadlines
- Willingness to strive for excellence by producing work that is free of errors and mistakes
- Desire to delight both customers and coworkers by offering encouragement, fostering teamwork and addressing conflict appropriately
- Commitment to making improvements company wide
- Demonstrated competence using Microsoft Office
- Good organizational skills.
- General office skills such as filing, scanning, and office etiquette.
- Ability to maintain a professional and respectful relationship with coworkers and company.
Compensation Package
